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

The Methodist Hospital Research Institute20 enrolled

Overview

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

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Electro-acupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Houston Methodist Neal Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment 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

Secondary Outcomes

Change in Neuropathic Pain After a 10-treatment EA Program

The change in neuropathic pain after a 10-treatment EA program in subjects with CIPN, was assessed by the Brief Pain Inventory Short Form (BPI-SF) at Baseline, 2-Week Post EA, and 3 Month Post EA. 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: 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

Assessed by the Total Outcome Index (TOI), including the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale at Baseline, 2-Week Post EA, and 3 Month Post EA. The Total Outcome Index (TOI) ranges from 0 to 100, with higher scores consistently indicating better outcomes. Items are rated on a 0-4 Likert scale and negatively worded items are reverse scored so that higher values always reflect better health status. The neurotoxicity subscale score is calculated by summing the scored responses to the neurotoxicity items (with standard prorating if some items are missing), and the TOI is calculated by summing the Physical Well-Being, Functional Well-Being, and Neurotoxicity subscale scores. Lower scores on either measure indicate worse symptoms or functioning, while higher scores reflect improvement or better quality of life related to neurotoxicity.

Time frame: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)

Data from ClinicalTrials.gov

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