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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Electro-acupuncture

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Neal Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Electro-acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraepidermal Nerve Fiber (IENF) Density After a 10-treatment EA Program	Measure the change in intraepidermal nerve fiber (IENF) density after a 10-treatment EA program in subjects with CIPN	5 Months
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program	Measure the changes in serum levels of inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), TNF-α, IL-1, and IL-6 after a 10-treatment EA program in subjects with CIPN.	5 Months

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Publications and helpful links

General Publications

• Piccolo J, et al. Prevention and treatment of chemotherapy-induced peripheral neuropathy. Am J Health-Syst Pharm 2014;71:19-25
• Hershman DL, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2014;32:1941-67
• Balayssac D, et al. Chemotherapy-induced peripheral neuropathies: from clinical relevance to preclinical evidence. Expert Opin Drug Saf 2011;10:407-17
• Lichtman SM, et al. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Ann Oncol 2012;23:632-8.
• Seretny M, et al. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. Pain 2014;155:2461-70.
• Smith EML, et al. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. J Am Med Assoc 2013;309:1359-67
• Able SL, et al. Duloxetine treatment adherence across mental health and chronic pain conditions. Clinicoecon Outcomes Res 2014;6:75-81
• Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol 2008;85:355-75.
• Jeong H-J, et al. Regulatory effect of cytokine production in asthma patients by Sooji Chim (Koryo hand acupuncture therapy. Immunopharmacol Immunotoxicol 2002;24:265-74.
• Zijlstra FJ, et al. Anti-inflammatory actions of acupuncture. Mediators Inflamm 2003;12:59-69.
• Garrow AP, et al. Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT. Acupunct Med 2014;32:242-9.
• Zhang C, et al. Clinical effects of acupuncture for diabetic peripheral neuropathy. J Tradit Chin Med 2010;30:13-4.
• Schröder S, et al. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol 2007;14:276-81.
• Galantino ML, et al. Use of noninvasive electroacupuncture for the treatment of HIV-related peripheral neuropathy: a pilot study. J Altern Complement Med 1999;45:135-42.
• Beal, MW, et al. Acupuncture for symptom relief in HIV-positive adults: lessons learned from a pilot study. Altern Ther Health Med 2000;6:33-42.
• Wong R, et al. Acupuncture treatment for chemotherapy-induced peripheral neuropathy--a case series. Acupunct Med 2006;24:87-91
• Donald G.K., et al. Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med 2011;29:230-3.
• Xu W-R, et al. Clinical randomized controlled study on acupuncture for treatment of peripheral neuropathy induced by chemotherapeutic drugs. Zhongguo Zhen Jiu 2010;30:457-60.
• Wong R, et al. Phase 2 study of acupuncture-like transcutaneous nerve stimulation for chemotherapy-induced peripheral neuropathy. Integr Cancer Ther 2016;15:153-64.
• Garcia MK, et al. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol 2014;7:41.
• Schroeder G, et al. Acupuncture for chemotherapy-induced peripheral neuropathy (CIPN): a pilot study using neurography. Acupunct Med 2012;30:4-7.
• Greenlee H, et al. Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer. Breast Cancer Res Treat 2016;156:453-64

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2019
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRO00020813 (HMCC-BR18-002)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes