<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/NCT03291574</url>
  </required_header>
  <id_info>
    <org_study_id>LC2015L45</org_study_id>
    <nct_id>NCT03291574</nct_id>
  </id_info>
  <brief_title>Perioperative Electroacupuncture for Gastric Cancer Patients After Gastrectomy</brief_title>
  <official_title>Effect of Perioperative Electroacupuncture After Gastrectomy for Gastric Cancer Patients on Rapid Rehabilitation: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the effect of Perioperative Electroacupuncture on rapid rehabilitation for the&#xD;
      gastric cancer patients after gastrectomy .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on&#xD;
      the clinicaltrail.gov. Quality assurance plan: every participant is enrolled or excluded by&#xD;
      two practiced investigators. And two investigators participated in all steps of the trail,&#xD;
      including the record of the data, and the investigators will compare the data. If the data is&#xD;
      consistent, the investigators would record the data; if not, the data would be checked and&#xD;
      decided by the two investigators. All the steps and data are site monitored and audited by&#xD;
      the workers of research and financial department of National Cancer Center/ Cancer Hospital,&#xD;
      Chinese Academy of Medical Sciences. Data check: the investigators compare data entered into&#xD;
      the registry against predefined rules for range or consistency with other data fields in the&#xD;
      registry. Source data verification to assess the accuracy, completeness, or&#xD;
      representativeness of registry data by comparing the data to external data sources, including&#xD;
      medical records and electronic case report forms. Data dictionary that contains detailed&#xD;
      descriptions of each variable used by the registry, including the source of the variable,&#xD;
      coding information, and normal ranges if relevant.&#xD;
&#xD;
      Standard Operating Procedures to address registry operations and analysis activities, such as&#xD;
      participants recruitment, data collection, data management, data analysis, reporting for&#xD;
      adverse events, and change management. All registry operations would be done according to&#xD;
      specific steps, and by two practiced investigators. Sample size assessment to specify the&#xD;
      number of participants or participant years necessary to demonstrate an effect. According to&#xD;
      the formula to differ advantages and disadvantages, the investigators need at least 70&#xD;
      participants to take part in the trail.&#xD;
&#xD;
      The investigators can recruit about 35 participants every year according to previous&#xD;
      experiences, so the investigators should recruit at least for two years. Plan for missing&#xD;
      data: the investigators would collect as much data as possible, and the investigators exclude&#xD;
      the participants who cannot cooperate on recruitment. And the investigators manage situations&#xD;
      according to statistical principles where variables are reported as missing, unavailable,&#xD;
      &quot;non-reported,&quot; uninterpretable, or considered missing because of data inconsistency or&#xD;
      out-of-range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze&#xD;
      the difference of survival time between the two groups, and the local control rate of the two&#xD;
      groups would be compared by chi square test. Statistical analyses would be performed by using&#xD;
      IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P&#xD;
      &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal function score</measure>
    <time_frame>day 1 after surgery</time_frame>
    <description>Using scale to evaluate the function of gastrointest after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal function score</measure>
    <time_frame>day 3 after surgery</time_frame>
    <description>Using scale to evaluate the function of gastrointest after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal function score</measure>
    <time_frame>day 5 after surgery</time_frame>
    <description>Using scale to evaluate the function of gastrointest after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal function score</measure>
    <time_frame>day 7 after surgery</time_frame>
    <description>Using scale to evaluate the function of gastrointest after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical fitness index</measure>
    <time_frame>day 1 after surgery</time_frame>
    <description>The recovery of physical fitness index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness index</measure>
    <time_frame>day 3 after surgery</time_frame>
    <description>The recovery of physical fitness index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness index</measure>
    <time_frame>day 5 after surgery</time_frame>
    <description>The recovery of physical fitness index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness index</measure>
    <time_frame>day 7 after surgery</time_frame>
    <description>The recovery of physical fitness index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Acupuncture</condition>
  <condition>Gastrointestinal Function</condition>
  <arm_group>
    <arm_group_label>Electroacupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham electroacupuncture group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.</description>
    <arm_group_label>Electroacupuncture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham electroacupuncture</intervention_name>
    <description>Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.</description>
    <arm_group_label>Sham electroacupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with gastric cancer who undergoing gastrectomy.&#xD;
&#xD;
          2. The life expectancy will be more than 3 months.&#xD;
&#xD;
          3. Voluntary participation, Signing informed consent and have good compliance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who has a history of abdominal surgery, radiotherapy, and chemotherapy.&#xD;
&#xD;
          2. Patient who combined with abdominal lymph node metastasis or distant organ metastasis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>chenefeng Wang, B.A</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chengfeng Wang, B.A</last_name>
    <phone>8613811370062</phone>
    <email>lifeofwater@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>chengfeng Wang, B.A</last_name>
      <phone>8613811370062</phone>
      <email>lifeofwater@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Chengfeng Wang</investigator_full_name>
    <investigator_title>Director of Department of pancreatic and gastric Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03291574
org study id: LC2015L45
nct id: NCT03291574
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate the effect of Perioperative Electroacupuncture on rapid rehabilitation for the
      gastric cancer patients after gastrectomy .
The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on
      the clinicaltrail.gov. Quality assurance plan: every participant is enrolled or excluded by
      two practiced investigators. And two investigators participated in all steps of the trail,
      including the record of the data, and the investigators will compare the data. If the data is
      consistent, the investigators would record the data; if not, the data would be checked and
      decided by the two investigators. All the steps and data are site monitored and audited by
      the workers of research and financial department of National Cancer Center/ Cancer Hospital,
      Chinese Academy of Medical Sciences. Data check: the investigators compare data entered into
      the registry against predefined rules for range or consistency with other data fields in the
      registry. Source data verification to assess the accuracy, completeness, or
      representativeness of registry data by comparing the data to external data sources, including
      medical records and electronic case report forms. Data dictionary that contains detailed
      descriptions of each variable used by the registry, including the source of the variable,
      coding information, and normal ranges if relevant.

      Standard Operating Procedures to address registry operations and analysis activities, such as
      participants recruitment, data collection, data management, data analysis, reporting for
      adverse events, and change management. All registry operations would be done according to
      specific steps, and by two practiced investigators. Sample size assessment to specify the
      number of participants or participant years necessary to demonstrate an effect. According to
      the formula to differ advantages and disadvantages, the investigators need at least 70
      participants to take part in the trail.

      The investigators can recruit about 35 participants every year according to previous
      experiences, so the investigators should recruit at least for two years. Plan for missing
      data: the investigators would collect as much data as possible, and the investigators exclude
      the participants who cannot cooperate on recruitment. And the investigators manage situations
      according to statistical principles where variables are reported as missing, unavailable,
      "non-reported," uninterpretable, or considered missing because of data inconsistency or
      out-of-range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze
      the difference of survival time between the two groups, and the local control rate of the two
      groups would be compared by chi square test. Statistical analyses would be performed by using
      IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P
      < 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Gastrointestinal function score
time frame: day 1 after surgery
description: Using scale to evaluate the function of gastrointest after surgery
measure: Gastrointestinal function score
time frame: day 3 after surgery
description: Using scale to evaluate the function of gastrointest after surgery
measure: Gastrointestinal function score
time frame: day 5 after surgery
description: Using scale to evaluate the function of gastrointest after surgery
measure: Gastrointestinal function score
time frame: day 7 after surgery
description: Using scale to evaluate the function of gastrointest after surgery
measure: Physical fitness index
time frame: day 1 after surgery
description: The recovery of physical fitness index
measure: Physical fitness index
time frame: day 3 after surgery
description: The recovery of physical fitness index
measure: Physical fitness index
time frame: day 5 after surgery
description: The recovery of physical fitness index
measure: Physical fitness index
time frame: day 7 after surgery
description: The recovery of physical fitness index
arm group label: Electroacupuncture group
arm group type: Experimental
description: Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu
arm group label: Sham electroacupuncture group
arm group type: Placebo Comparator
description: Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu
intervention type: Procedure
intervention name: Electroacupuncture
description: Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
arm group label: Electroacupuncture group
intervention type: Procedure
intervention name: Sham electroacupuncture
description: Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
arm group label: Sham electroacupuncture group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: chenefeng Wang, B.A
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Chengfeng Wang, B.A
phone: 8613811370062
email: lifeofwater@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Chengfeng Wang
investigator title: Director of Department of pancreatic and gastric Surgery
mesh term: Stomach Neoplasms