Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- whether acupuncture reduces common symptoms
研究概览
简要总结
This is a prospective randomized controlled trial to obtain preliminary data for the design of a future definitive efficacy study. A randomized controlled trial is needed because comparison to historical data would be biased. The investigators will use sham acupuncture as the control to account for effect from attention from and interaction with the therapist.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or above (those age below 21 are usually treated in the Pediatric Transplant Service)
- •Diagnosis of multiple myeloma
- •Scheduled to receive conditioning chemotherapy followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
排除标准
- •Absolute neutrophil count less than 200/microliter
- •Platelet count less than 20,000/microliter
- •Acupuncture treatment in the preceding 4 weeks prior to Day 1
结局指标
主要结局
whether acupuncture reduces common symptoms
时间窗: 2 years
In patients undergoing chemotherapy prior to hematopoietic stem cell transplantation. The primary endpoint is the area-under-curve (AUC) for MDASI total score from Day -2 to Day 5. MDASI scores are assessed daily by having the patient fill out the questionnaire. Severity is assessed for the 13 core MDASI symptom items (pain, fatigue, nausea, disturbed sleep, distress etc..) AUC for MDASI total score from Day -2 to Day 5 will be compared between the acupuncture group and the sham acupuncture group.
次要结局
- to assess the effect size for each symptom(2 years)