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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
Houston Methodist Neal Cancer Center
Houston, Texas, United States
Feasibility of a 10-treatment Electro-Acupuncture (EA) program
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
Time frame: 5 Months
Change in neuropathic pain after a 10-treatment EA program
To determine the change in neuropathic pain after a 10-treatment EA program in subjects with CIPN, as assessed by the Brief Pain Inventory Short Form (BPI-SF). Used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. Pain and interference are rated on a 10-point scale (0 = no pain/interference and 10 = pain as bad as you can imagine/complete interference). Higher scores mean worse outcomes.
Time frame: 5 Months
Change in quality of life after a 10-treatment EA program
To determine the change in quality of life after a 10-treatment EA program in subjects with CIPN, as assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale. The FACT/GOG-NTX subscale evaluates the subject's physical, social/family, emotional, and functional well-being. Items are scored on a scale ranging from 0 (not at all) to 4 (very much). Higher scores mean worse outcomes.
Time frame: 5 Months
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