<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195921</url>
  </required_header>
  <id_info>
    <org_study_id>2014CB543201-02</org_study_id>
    <nct_id>NCT02195921</nct_id>
  </id_info>
  <brief_title>Acupuncture for Chemotherapy-Induced Nausea and Vomiting</brief_title>
  <official_title>Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to clarify whether the matching acupoints is more effective than&#xD;
      a single point by electroacupuncture in the management of chemotherapy-induced nausea and&#xD;
      vomiting .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36,&#xD;
      CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and&#xD;
      Adverse Eventswill be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Nausea</measure>
    <time_frame>5 days</time_frame>
    <description>Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Times Vomiting Occurs After Chemotherapy</measure>
    <time_frame>5 days</time_frame>
    <description>The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rhodes Index of Nausea, Vomiting and Retching</measure>
    <time_frame>5 days</time_frame>
    <description>The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy</measure>
    <time_frame>5 days</time_frame>
    <description>Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Grading of Constipation and Diarrhea</measure>
    <time_frame>5 days</time_frame>
    <description>The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrogastrogram</measure>
    <time_frame>5 days</time_frame>
    <description>We deleted this evaluation method due to weak correlation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Assessment of Quality of Life</measure>
    <time_frame>5 days</time_frame>
    <description>Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Assessment of Anxiety and Depression</measure>
    <time_frame>5 days</time_frame>
    <description>Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Routine Examination</measure>
    <time_frame>5 days</time_frame>
    <description>We deleted this evaluation method due to weak correlation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Electrocardiogram</measure>
    <time_frame>5 days</time_frame>
    <description>We deleted this evaluation method due to weak correlation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hepatic and Renal Function</measure>
    <time_frame>5 days</time_frame>
    <description>We deleted this evaluation method due to weak correlation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Other Adverse Effect During the Chemotherapy</measure>
    <time_frame>5 days</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Single point CV12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single point ST36</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ST36+CV12 acupoints</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>only antiemetics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>single point Zhongwan(CV12) plus antiemetic drug</intervention_name>
    <description>All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until &quot;De Qi&quot; (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.</description>
    <arm_group_label>Single point CV12</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>single point Zusanli(ST36) plus antiemetic drug</intervention_name>
    <description>A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until &quot;De Qi&quot; (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.</description>
    <arm_group_label>Single point ST36</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug</intervention_name>
    <description>Stimulating both Zusanli(ST36)and Zhongwan(CV12)</description>
    <arm_group_label>ST36+CV12 acupoints</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>only antiemetic drug</intervention_name>
    <description>received routine antiemetic treatment</description>
    <arm_group_label>only antiemetics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be diagnosed as cancer and need to accept chemotherapy.&#xD;
&#xD;
          2. The score of Karnofsky ≥70&#xD;
&#xD;
          3. Patients of either gender and older than 18 years&#xD;
&#xD;
          4. Patients receiving chemotherapy both outpatients and inpatients&#xD;
&#xD;
          5. Patients receiving chemotherapy either he first or multiple cycle, but the patient&#xD;
             will be taken in only one time&#xD;
&#xD;
          6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy&#xD;
             programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)&#xD;
&#xD;
          7. Life expectancy≥ 6 months&#xD;
&#xD;
          8. Willing to participate in the study and be randomized into one of the four study&#xD;
             groups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. To receive radiotherapy and chemotherapy&#xD;
&#xD;
          2. Gastrointestinal tumors&#xD;
&#xD;
          3. Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and&#xD;
             TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)&#xD;
&#xD;
          4. Presence of cardiac pacemaker&#xD;
&#xD;
          5. Active skin infection&#xD;
&#xD;
          6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte&#xD;
             disturbances)&#xD;
&#xD;
          7. Patients unable to provide self-care or communication&#xD;
&#xD;
          8. Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal&#xD;
             obstruction)&#xD;
&#xD;
          9. Brain metastases&#xD;
&#xD;
         10. Women in pregnant and lactating period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Guo</last_name>
    <role>Study Director</role>
    <affiliation>Tianjin University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>301617</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>December 27, 2020</results_first_submitted>
  <results_first_submitted_qc>January 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 11, 2021</results_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Yi Guo</investigator_full_name>
    <investigator_title>Dean of Traditional Chinese Medicine School</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antiemetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>160 patients were enrolled randomly assigned to the CV12 (n = 40), ST36 (n = 40), DA (n = 40) and control (n = 40) groups. One participant in each of the CV12 and control groups was further excluded due to missing sessions, and one was excluded in the DA group because of repeated enrollment during the study period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Point CV12</title>
          <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="P2">
          <title>Single Point ST36</title>
          <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
        </group>
        <group group_id="P3">
          <title>Matching Points ST36+CV12</title>
          <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="P4">
          <title>Only Antiemetics</title>
          <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="39"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patient demographic characteristics were similar among the four groups at baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Single Point CV12</title>
          <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="B2">
          <title>Single Point ST36</title>
          <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
        </group>
        <group group_id="B3">
          <title>Matching Points ST36+CV12</title>
          <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="B4">
          <title>Only Antiemetics</title>
          <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="39"/>
            <count group_id="B4" value="40"/>
            <count group_id="B5" value="159"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="7.23"/>
                    <measurement group_id="B2" value="55.4" spread="9.03"/>
                    <measurement group_id="B3" value="51.7" spread="11.37"/>
                    <measurement group_id="B4" value="53.7" spread="7.16"/>
                    <measurement group_id="B5" value="53" spread="8.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Nausea</title>
        <description>Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Nausea</title>
          <description>Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="24" upper_limit="37"/>
                    <measurement group_id="O2" value="47" lower_limit="40" upper_limit="54"/>
                    <measurement group_id="O3" value="54" lower_limit="47" upper_limit="61"/>
                    <measurement group_id="O4" value="53" lower_limit="46" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Times Vomiting Occurs After Chemotherapy</title>
        <description>The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CV12</title>
            <description>Stimulated CV12</description>
          </group>
          <group group_id="O2">
            <title>ST36</title>
            <description>Stimulated ST36</description>
          </group>
          <group group_id="O3">
            <title>CV12+ST36</title>
            <description>Stimulated CV12+ST36</description>
          </group>
          <group group_id="O4">
            <title>Control</title>
            <description>Antiemetic only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times Vomiting Occurs After Chemotherapy</title>
          <description>The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.</description>
          <units>number of times for patients</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" lower_limit="0.28" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.54" lower_limit="0.35" upper_limit="0.74"/>
                    <measurement group_id="O3" value="0.78" lower_limit="0.52" upper_limit="1.05"/>
                    <measurement group_id="O4" value="0.53" lower_limit="0.32" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rhodes Index of Nausea, Vomiting and Retching</title>
        <description>The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected.Due to its relatively weak specificity, the data was not collected. we replaced it with (visual analog scale) VAS and number of times of vomiting occurs which were recorded in the first and second primary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CV12</title>
            <description>Stimulated CV12</description>
          </group>
          <group group_id="O2">
            <title>ST36</title>
            <description>Stimulated ST36</description>
          </group>
          <group group_id="O3">
            <title>CV12+ST36</title>
            <description>Stimulated CV12+ST36</description>
          </group>
          <group group_id="O4">
            <title>Control</title>
            <description>Antiemetic only</description>
          </group>
        </group_list>
        <measure>
          <title>Rhodes Index of Nausea, Vomiting and Retching</title>
          <description>The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .</description>
          <population>Data were not collected.Due to its relatively weak specificity, the data was not collected. we replaced it with (visual analog scale) VAS and number of times of vomiting occurs which were recorded in the first and second primary outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy</title>
        <description>Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.</description>
        <time_frame>5 days</time_frame>
        <posting_date>12/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Grading of Constipation and Diarrhea</title>
        <description>The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Grading of Constipation and Diarrhea</title>
          <description>The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Electrogastrogram</title>
        <description>We deleted this evaluation method due to weak correlation.</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Electrogastrogram</title>
          <description>We deleted this evaluation method due to weak correlation.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Assessment of Quality of Life</title>
        <description>Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>the Assessment of Quality of Life</title>
          <description>Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" lower_limit="43" upper_limit="50"/>
                    <measurement group_id="O2" value="47" lower_limit="42.25" upper_limit="49"/>
                    <measurement group_id="O3" value="45" lower_limit="36" upper_limit="47"/>
                    <measurement group_id="O4" value="45" lower_limit="39" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Assessment of Anxiety and Depression</title>
        <description>Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>the Assessment of Anxiety and Depression</title>
          <description>Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="6" upper_limit="8"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="8"/>
                    <measurement group_id="O3" value="8" lower_limit="7" upper_limit="9"/>
                    <measurement group_id="O4" value="7" lower_limit="6" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Routine Examination</title>
        <description>We deleted this evaluation method due to weak correlation.</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Routine Examination</title>
          <description>We deleted this evaluation method due to weak correlation.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Electrocardiogram</title>
        <description>We deleted this evaluation method due to weak correlation.</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Electrocardiogram</title>
          <description>We deleted this evaluation method due to weak correlation.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hepatic and Renal Function</title>
        <description>We deleted this evaluation method due to weak correlation.</description>
        <time_frame>5 days</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Hepatic and Renal Function</title>
          <description>We deleted this evaluation method due to weak correlation.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Other Adverse Effect During the Chemotherapy</title>
        <time_frame>5 days</time_frame>
        <population>Recorded in Adverse Events</population>
        <group_list>
          <group group_id="O1">
            <title>Single Point CV12</title>
            <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O2">
            <title>Single Point ST36</title>
            <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
          </group>
          <group group_id="O3">
            <title>Matching Points ST36+CV12</title>
            <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
          </group>
          <group group_id="O4">
            <title>Only Antiemetics</title>
            <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
          </group>
        </group_list>
        <measure>
          <title>Other Adverse Effect During the Chemotherapy</title>
          <population>Recorded in Adverse Events</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 days after chemotherapy</time_frame>
      <desc>Electroacupuncture may be a safe treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>Single Point CV12</title>
          <description>choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a &quot;de Qi&quot; sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="E2">
          <title>Single Point ST36</title>
          <description>choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
single point Zusanli(ST36) plus antiemetic drug</description>
        </group>
        <group group_id="E3">
          <title>ST36+CV12</title>
          <description>Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a &quot;de Qi&quot; sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.&#xD;
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug</description>
        </group>
        <group group_id="E4">
          <title>Only Antiemetics</title>
          <description>The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.&#xD;
only antiemetic drug</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2.54</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial</name_or_title>
      <organization>Tianjin University of Traditional Chinese Medicine</organization>
      <phone>+86 13920921016</phone>
      <email>guoyi_168@163.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195921
org study id: 2014CB543201-02
nct id: NCT02195921
lead sponsor: 
has dmc: Yes
The purpose of this study is to clarify whether the matching acupoints is more effective than
      a single point by electroacupuncture in the management of chemotherapy-induced nausea and
      vomiting .
Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36,
      CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and
      Adverse Eventswill be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Participants With Nausea
time frame: 5 days
description: Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
measure: Number of Times Vomiting Occurs After Chemotherapy
time frame: 5 days
description: The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
measure: Rhodes Index of Nausea, Vomiting and Retching
time frame: 5 days
description: The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
measure: Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
time frame: 5 days
description: Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
measure: Grading of Constipation and Diarrhea
time frame: 5 days
description: The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
measure: Electrogastrogram
time frame: 5 days
description: We deleted this evaluation method due to weak correlation.
measure: the Assessment of Quality of Life
time frame: 5 days
description: Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status
measure: the Assessment of Anxiety and Depression
time frame: 5 days
description: Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.
measure: Blood Routine Examination
time frame: 5 days
description: We deleted this evaluation method due to weak correlation.
measure: Electrocardiogram
time frame: 5 days
description: We deleted this evaluation method due to weak correlation.
measure: Hepatic and Renal Function
time frame: 5 days
description: We deleted this evaluation method due to weak correlation.
measure: Other Adverse Effect During the Chemotherapy
time frame: 5 days
arm group label: Single point CV12
arm group type: Experimental
description: choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a "de Qi" sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
arm group label: Single point ST36
arm group type: Experimental
description: choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
arm group label: ST36+CV12 acupoints
arm group type: Experimental
description: Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
arm group label: only antiemetics
arm group type: Active Comparator
description: The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
intervention type: Other
intervention name: single point Zhongwan(CV12) plus antiemetic drug
description: All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
arm group label: Single point CV12
intervention type: Other
intervention name: single point Zusanli(ST36) plus antiemetic drug
description: A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
arm group label: Single point ST36
intervention type: Other
intervention name: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
description: Stimulating both Zusanli(ST36)and Zhongwan(CV12)
arm group label: ST36+CV12 acupoints
intervention type: Drug
intervention name: only antiemetic drug
description: received routine antiemetic treatment
arm group label: only antiemetics
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yi Guo
role: Study Director
affiliation: Tianjin University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin University of Traditional Chinese Medicine
investigator full name: Yi Guo
investigator title: Dean of Traditional Chinese Medicine School
mesh term: Nausea
mesh term: Vomiting
mesh term: Antiemetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 