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Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

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ClinicalTrials.gov Identifier: NCT03753399
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Haibo Zhang, Guangzhou University of Traditional Chinese Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-dose acupuncture
Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
Procedure: acupuncture
Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Experimental: Low-dose acupuncture
Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
Procedure: acupuncture
Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

No Intervention: Usual care
Chemotherapy without acupuncture



Primary Outcome Measures :
  1. FACT-Gastric Trial Outcome Index (TOI) [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    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.

  2. Chinese version of Edmonton symptom assessment scale (C-ESAS) [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    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.

  3. 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). ]
    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.

  4. 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) ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.

  2. Adherence to chemotherapy [ Time Frame: At the end of 3 cycles of treatment (21 days for each cycle). ]
    Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy

  3. Inflammatory factors [ Time Frame: At the end of 3 cycles of treatment (21 days for each cycle). ]
    Inflammatory factors detected with ELISA

  4. Myeloid-derived suppressor cells [ Time Frame: At the end of 3 cycles of treatment (21 days for each cycle). ]
    Myeloid-derived suppressor cells detected using flow cytometry

  5. T lymph cells [ Time Frame: At the end of 3 cycles of treatment (21 days for each cycle). ]
    T lymph cells detected using flow cytometry

  6. Circulating tumor cells [ Time Frame: At the end of 3 cycles of treatment (21 days for each cycle). ]
    Circulating tumor cells detected using microfluidic chip



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
  • 2.Pathological stage II or stage III;
  • 3.Without tumor recurrence confirmed by image examination;
  • 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
  • 5.Age:18~75 years old;
  • 6.ECOG score≤ 2;
  • 7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min; 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN;
  • 8. Can understand the study well and finish the questionnaires in this study;
  • 9. With the written informed consent.

Exclusion Criteria:

  • 1. Can not finish the baseline assessment;
  • 2. Needle phobia;
  • 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
  • 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
  • 5. Implanted with heart pacemaker;
  • 6. Has accepted neoadjuvant radiotherapy before surgery;
  • 7. Planning to accept adjuvant radiotherapy after surgery;
  • 8. With active infection;
  • 9. Acupuncture treatment within the previous 6 weeks;
  • 10.Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753399


Contacts
Contact: Yanjuan Zhu, Dr 86 20 81887233 ext 34830 zlbzyjzzl@gzucm.edu.cn
Contact: Xin Qu, Dr 86 20 81887233 ext 34830 dynyk@gzucm.edu.cn

Locations
China, Guangdong
The first affiliated hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianjun Peng, Dr.    86 20 28823388    aidigua@hotmail.com   
Guangdong Provincial Hospital of Chinese Medicine Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yanjuan Zhu, Dr.    86 20 81887233 ext 34830    zlbzyjzzl@gzucm.edu.cn   
Contact: Xin Qu, Dr.    86 20 81887233 ext 34830    dynyk@gzucm.edu.cn   
Principal Investigator: Haibo Zhang, Professor         
China, Jiangsu
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine Not yet recruiting
Nanjing, Jiangsu, China, 210000
Contact: Xiaoyu Wu, Dr    86 25 86617141    wuxiaoyu@medmail.com.cn   
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Responsible Party: Haibo Zhang, Professor, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03753399     History of Changes
Other Study ID Numbers: 2018KT1226
2017YFC1700603 ( Other Grant/Funding Number: The National Key Research and Development Program of China )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haibo Zhang, Guangzhou University of Traditional Chinese Medicine:
Gastric cancer
Acupuncture
Quality of life
Adjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases