<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/NCT02195908</url>
  </required_header>
  <id_info>
    <org_study_id>2014CB543201-01</org_study_id>
    <nct_id>NCT02195908</nct_id>
  </id_info>
  <brief_title>The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting</brief_title>
  <official_title>The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Basic Research Program, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 are more effective&#xD;
      than a single point by electro-acupuncture in the management of chemotherapy-induced nausea&#xD;
      and vomiting .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>the frequency of Nausea and Vomiting</measure>
    <time_frame>6days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the grading of constipation and diarrhea</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>electrogastrogram</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the assessment of quality of life</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the assessment of Anxiety and Depression</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>blood routine examination</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>electrocardiogram</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>hepatic and renal function</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>other adverse effect during the chemotherapy</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Single point PC6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single point CV12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>choose another 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching points PC6+CV12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Choose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a &quot;de Qi&quot; sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>only antiemetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive standard antiemetic alone. Standard antiemetic for all groups is 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 chemotherapy, and lasting for 3-5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>single point Neiguan(PC6) plus antiemetic drug</intervention_name>
    <arm_group_label>Single point PC6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>single point Zhongwan(CV12) plus antiemetic drug</intervention_name>
    <arm_group_label>Single point CV12</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug</intervention_name>
    <arm_group_label>Matching points PC6+CV12</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>only antiemetic drug</intervention_name>
    <arm_group_label>only antiemetic</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 the 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>
  <location>
    <facility>
      <name>Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300193</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</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>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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>the Dean of Acupuncture and Moxibustion College</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>
  <pending_results>
    <submitted>January 12, 2021</submitted>
    <returned>February 1, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02195908
org study id: 2014CB543201-01
nct id: NCT02195908
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to clarify whether the matching acupoints are more effective
      than a single point by electro-acupuncture in the management of chemotherapy-induced nausea
      and vomiting .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the frequency of Nausea and Vomiting
time frame: 6days
measure: the grading of constipation and diarrhea
time frame: 3 weeks
measure: electrogastrogram
time frame: 3 weeks
measure: the assessment of quality of life
time frame: 3 weeks
measure: the assessment of Anxiety and Depression
time frame: 3 weeks
measure: blood routine examination
time frame: 3 weeks
measure: electrocardiogram
time frame: 3 weeks
measure: hepatic and renal function
time frame: 3 weeks
measure: other adverse effect during the chemotherapy
time frame: 3 weeks
arm group label: Single point PC6
arm group type: Experimental
description: choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
arm group label: Single point CV12
arm group type: Experimental
description: choose another 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
arm group label: Matching points PC6+CV12
arm group type: Experimental
description: Choose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
arm group label: only antiemetic
arm group type: Active Comparator
description: The control group will receive standard antiemetic alone. Standard antiemetic for all groups is 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 chemotherapy, and lasting for 3-5 days.
intervention type: Other
intervention name: single point Neiguan(PC6) plus antiemetic drug
arm group label: Single point PC6
intervention type: Other
intervention name: single point Zhongwan(CV12) plus antiemetic drug
arm group label: Single point CV12
intervention type: Other
intervention name: matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug
arm group label: Matching points PC6+CV12
intervention type: Drug
intervention name: only antiemetic drug
arm group label: only antiemetic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin University of Traditional Chinese Medicine
investigator full name: Yi Guo
investigator title: the Dean of Acupuncture and Moxibustion College
mesh term: Nausea
mesh term: Vomiting
mesh term: Antiemetics
submitted: January 12, 2021
returned: February 1, 2021