Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy

A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Pregnant