Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- change in the proportion of patients with a CIPN severity
研究概览
简要总结
The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Age ≥ 18 years old
- •Solid tumor survivors with no evidence of disease
- •Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)
- •Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
- •If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
排除标准
- •Patients with a pacemaker
- •Prior acupuncture treatment within 5 years of enrollment
研究组 & 干预措施
Acupuncture Treatment Group
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
干预措施: Acupuncture (Procedure)
Acupuncture Treatment Group
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
干预措施: questionnaires (Behavioral)
Sham Acupuncture Treatment Group
Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.
干预措施: Sham Acupuncture (Procedure)
Sham Acupuncture Treatment Group
Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.
干预措施: questionnaires (Behavioral)
Usual Care Group
Twelve weeks of usual care.
干预措施: Usual Care Group (Other)
Usual Care Group
Twelve weeks of usual care.
干预措施: questionnaires (Behavioral)
结局指标
主要结局
change in the proportion of patients with a CIPN severity
时间窗: up to 12 weeks
according to the NCI-CTC 4.0
次要结局
未报告次要终点