A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
研究概览
简要总结
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN.
详细描述
This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female aged ≥18 years
- •Received curative-intent chemotherapy (i.e., paclitaxel, docetaxel, nab-paclitaxel, carboplatin, oxaliplatin, vinorelbine, ixabepilone, or vincristine) ≥3 months prior to the start of EA treatment
- •Persistent Grade ≥2 peripheral neuropathy in the fingers or toes according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
- •Eastern Cooperative Oncology Group performance status of ≤2 (see Section 13.3)
- •Willing and able to provide written informed consent for the study.
排除标准
- •Documented medical history of neuropathy resulting from nerve compression (e.g., carpal tunnel syndrome, radiculopathy, or spinal stenosis)
- •Severe coagulopathy or bleeding disorder, per the treating physician's discretion
- •Presence of cellulitis or other skin infection or condition that would preclude placement of acupuncture needles into the hands or feet
- •Diabetes unless Hgb A1c <7.5%
- •Unstable cardiac disease
- •Pacemaker
- •Metal plates
- •Known psychiatric disorder that would interfere with cooperation with the requirements of the study
研究组 & 干预措施
Electro-Acupuncture (EA)
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
干预措施: Electro-acupuncture (Device)
结局指标
主要结局
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
时间窗: 5 Months
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
Feasibility of a 10-treatment Electro-Acupuncture (EA) program
时间窗: 5 Months
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
次要结局
- Change in Neuropathic Pain After a 10-treatment EA Program(Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months))
- Change in Quality of Life After a 10-treatment EA Program(Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months))
- Change in neuropathic pain after a 10-treatment EA program(5 Months)
- Change in quality of life after a 10-treatment EA program(5 Months)