<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/NCT03753399</url>
  </required_header>
  <id_info>
    <org_study_id>2018KT1226</org_study_id>
    <secondary_id>2017YFC1700603</secondary_id>
    <nct_id>NCT03753399</nct_id>
  </id_info>
  <brief_title>Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study</brief_title>
  <official_title>Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Nanjing University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric&#xD;
      cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will&#xD;
      randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the&#xD;
      first 3 cycles of adjuvant chemotherapy after resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">April 27, 2020</completion_date>
  <primary_completion_date type="Actual">April 27, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FACT-Gastric Trial Outcome Index (TOI)</measure>
    <time_frame>At the end of Cycle 3 (each cycle is 21 days)</time_frame>
    <description>FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chinese version of Edmonton symptom assessment scale (C-ESAS)</measure>
    <time_frame>At the end of Cycle 3 (each cycle is 21 days)</time_frame>
    <description>Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average trajectory of FACT-Gastric TOI over time</measure>
    <time_frame>Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).</time_frame>
    <description>FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average trajectory of C-ESAS over time</measure>
    <time_frame>Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)</time_frame>
    <description>Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.</time_frame>
    <description>Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to chemotherapy</measure>
    <time_frame>At the end of 3 cycles of treatment (21 days for each cycle).</time_frame>
    <description>Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Inflammatory factors in plasma detected with liquid chip</measure>
    <time_frame>At the end of 3 cycles of treatment (21 days for each cycle).</time_frame>
    <description>Plasma will be stored at -80℃. Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment. the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry</measure>
    <time_frame>At the end of 3 cycles of treatment (21 days for each cycle).</time_frame>
    <description>Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Circulating CD8+ T lymph cells detected using flow cytometry</measure>
    <time_frame>At the end of 3 cycles of treatment (21 days for each cycle).</time_frame>
    <description>CD8+ T lymph cells in peripheral blood will be detected using flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Circulating tumor cells detected using microfluidic chip</measure>
    <time_frame>At the end of 3 cycles of treatment (21 days for each cycle).</time_frame>
    <description>Circulating tumor cells in peripheral blood will be detected using microfluidic chip</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>High-dose acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-dose acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Chemotherapy without acupuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.</description>
    <arm_group_label>High-dose acupuncture</arm_group_label>
    <arm_group_label>Low-dose acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer&#xD;
             after R0 resection and D2 lymph node dissection;&#xD;
&#xD;
          -  2.Pathological stage II or stage III；&#xD;
&#xD;
          -  3.Without tumor recurrence confirmed by image examination;&#xD;
&#xD;
          -  4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant&#xD;
             chemotherapy;&#xD;
&#xD;
          -  5.Age:18~75 years old；&#xD;
&#xD;
          -  6.ECOG score≤ 2；&#xD;
&#xD;
          -  7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil&#xD;
             count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney&#xD;
             function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate&#xD;
             (Ccr)≥60ml/min； 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal&#xD;
             value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN；&#xD;
&#xD;
          -  8. Can understand the study well and finish the questionnaires in this study;&#xD;
&#xD;
          -  9. With the written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Can not finish the baseline assessment;&#xD;
&#xD;
          -  2. Needle phobia;&#xD;
&#xD;
          -  3. Currently diagnosed with psychiatric disorder (e.g., severe depression,&#xD;
             obsessive-compulsive disorder, or schizophrenia);&#xD;
&#xD;
          -  4. History of autoimmune diseases, hematological diseases or organ transplantation, or&#xD;
             long term use of hormones or immunosuppressors;&#xD;
&#xD;
          -  5. Implanted with heart pacemaker;&#xD;
&#xD;
          -  6. Has accepted neoadjuvant radiotherapy before surgery;&#xD;
&#xD;
          -  7. Planning to accept adjuvant radiotherapy after surgery;&#xD;
&#xD;
          -  8. With active infection;&#xD;
&#xD;
          -  9. Acupuncture treatment within the previous 6 weeks;&#xD;
&#xD;
          -  10.Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The first affiliated hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Nanjing University of Traditional Chinese Medicine</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Haibo Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753399
org study id: 2018KT1226
secondary id: 2017YFC1700603
nct id: NCT03753399
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric
      cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will
      randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the
      first 3 cycles of adjuvant chemotherapy after resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: FACT-Gastric Trial Outcome Index (TOI)
time frame: At the end of Cycle 3 (each cycle is 21 days)
description: FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
measure: Chinese version of Edmonton symptom assessment scale (C-ESAS)
time frame: At the end of Cycle 3 (each cycle is 21 days)
description: Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
measure: Average trajectory of FACT-Gastric TOI over time
time frame: Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
description: FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
measure: Average trajectory of C-ESAS over time
time frame: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)
description: Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.
description: Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.
measure: Adherence to chemotherapy
time frame: At the end of 3 cycles of treatment (21 days for each cycle).
description: Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy
measure: Concentration of Inflammatory factors in plasma detected with liquid chip
time frame: At the end of 3 cycles of treatment (21 days for each cycle).
description: Plasma will be stored at -80℃. Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment. the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports.
measure: Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry
time frame: At the end of 3 cycles of treatment (21 days for each cycle).
description: Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry
measure: Concentration of Circulating CD8+ T lymph cells detected using flow cytometry
time frame: At the end of 3 cycles of treatment (21 days for each cycle).
description: CD8+ T lymph cells in peripheral blood will be detected using flow cytometry
measure: Number of Circulating tumor cells detected using microfluidic chip
time frame: At the end of 3 cycles of treatment (21 days for each cycle).
description: Circulating tumor cells in peripheral blood will be detected using microfluidic chip
arm group label: High-dose acupuncture
arm group type: Experimental
description: Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
arm group label: Low-dose acupuncture
arm group type: Experimental
description: Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
arm group label: Usual care
arm group type: No Intervention
description: Chemotherapy without acupuncture
intervention type: Procedure
intervention name: acupuncture
description: Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
arm group label: High-dose acupuncture
arm group label: Low-dose acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou University of Traditional Chinese Medicine
investigator full name: Haibo Zhang
investigator title: Professor
mesh term: Stomach Neoplasms
sharing ipd: Undecided