Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Average trajectory of FACT-Gastric TOI over time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Average trajectory of FACT-Gastric TOI over time
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- 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).)
研究者
Haibo Zhang
Professor
Guangzhou University of Traditional Chinese Medicine