Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 11
- 主要终点
- Total AUC of FACT-Gastric TOI
研究概览
简要总结
In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-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 organ 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
Total AUC of FACT-Gastric TOI
时间窗: At the end of Cycle 3 ( 21 days for one 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 (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (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. TOI for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.
次要结局
- Total AUC of Modified Edmonton Symptom Assessment Scale(At the end of Cycle 3 ( 21 days for one cycle))
- Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(At the end of Cycle 3 ( 21 days for one cycle))
- Average trajectory of Modified Edmonton Symptom Assessment Scale(Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle))
- Total AUC of FACT-Gastric Scoring(At the end of Cycle 3 ( 21 days for one cycle))
- Average trajectory of FACT-Gastric TOI over time(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))
- Average trajectory of FACT-Gastric Scoring over time(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))
- Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle))