Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stomach Neoplasms
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
- Enrollment
- 66
- Locations
- 3
- Primary Endpoint
- Average trajectory of FACT-Gastric TOI over time
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Haibo Zhang
Professor
Guangzhou University of Traditional Chinese Medicine
Eligibility 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；
- •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；
- •Can understand the study well and finish the questionnaires in this study;
- •With the written informed consent.
Exclusion Criteria
- •Can not finish the baseline assessment;
- •Needle phobia;
- •Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
- •History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
- •Implanted with heart pacemaker;
- •Has accepted neoadjuvant radiotherapy before surgery;
- •Planning to accept adjuvant radiotherapy after surgery;
- •With active infection;
- •Acupuncture treatment within the previous 6 weeks;
- •10.Pregnant or lactating women.
Outcomes
Primary Outcomes
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.
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.
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.
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 Outcomes
- Adherence to chemotherapy(At the end of 3 cycles of treatment (21 days for each cycle).)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](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.)
- Concentration of Inflammatory factors in plasma detected with liquid chip(At the end of 3 cycles of treatment (21 days for each cycle).)
- Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry(At the end of 3 cycles of treatment (21 days for each cycle).)
- Number of Circulating tumor cells detected using microfluidic chip(At the end of 3 cycles of treatment (21 days for each cycle).)
- Concentration of Circulating CD8+ T lymph cells detected using flow cytometry(At the end of 3 cycles of treatment (21 days for each cycle).)