Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
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
- Change in Brief Pain Inventory-Short Form Score
研究概览
简要总结
This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.
详细描述
Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age>21 years
- •History of stage I-III breast cancer
- •Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
- •Signed informed consent
排除标准
- •Previous treatment with acupuncture in the last 12 months
- •Diabetic Neuropathy or other neurological conditions
- •Inflammatory, metabolic or neuropathic arthropathies
- •Current narcotic use
- •Severe concomitant illnesses
- •Severe coagulopathy or bleeding disorder
- •Dermatological disease within the acupuncture area
- •Have a pacemaker
研究组 & 干预措施
Electro-acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
干预措施: Electro-acupuncture (Device)
Sham acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
干预措施: Sham acupuncture (Device)
结局指标
主要结局
Change in Brief Pain Inventory-Short Form Score
时间窗: Baseline, 16 weeks
The change in neuropathic pain, as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, from baseline to 16 weeks, in the study group that received electro-acupuncture (intervention), was compared to the change in neuropathic pain in the study group that received sham acupuncture (control). Scores range from 0 (no pain)-10 (worst pain) with a higher score indicating worse outcome.
次要结局
- Change in FACT-TAX Score(Baseline, 16 weeks)
研究者
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University