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

NCT07455409 | Completed Results DMC FDA Device

• 1 other identifier: PRO00020813 (HMCC-BR18-002)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Other Outcomes (2)

• Change in Intraepidermal Nerve Fiber (IENF) Density After a 10-treatment EA Program

  5 Months

• Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program

  5 Months

Study Arms (1)

Electro-Acupuncture (EA)

EXPERIMENTAL

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

Interventions

Electro-acupuncture DEVICE

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.

Electro-Acupuncture (EA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Neal Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (22)

• Piccolo J, et al. Prevention and treatment of chemotherapy-induced peripheral neuropathy. Am J Health-Syst Pharm 2014;71:19-25

  BACKGROUND

• 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

  BACKGROUND

• Balayssac D, et al. Chemotherapy-induced peripheral neuropathies: from clinical relevance to preclinical evidence. Expert Opin Drug Saf 2011;10:407-17

  BACKGROUND

• 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.

  BACKGROUND

• Seretny M, et al. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. Pain 2014;155:2461-70.

  BACKGROUND

• 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

  BACKGROUND

• Able SL, et al. Duloxetine treatment adherence across mental health and chronic pain conditions. Clinicoecon Outcomes Res 2014;6:75-81

  BACKGROUND

• Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol 2008;85:355-75.

  BACKGROUND

• 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.

  BACKGROUND

• Zijlstra FJ, et al. Anti-inflammatory actions of acupuncture. Mediators Inflamm 2003;12:59-69.

  BACKGROUND

• Garrow AP, et al. Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT. Acupunct Med 2014;32:242-9.

  BACKGROUND

• Zhang C, et al. Clinical effects of acupuncture for diabetic peripheral neuropathy. J Tradit Chin Med 2010;30:13-4.

  BACKGROUND

• Schröder S, et al. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol 2007;14:276-81.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Wong R, et al. Acupuncture treatment for chemotherapy-induced peripheral neuropathy--a case series. Acupunct Med 2006;24:87-91

  BACKGROUND

• Donald G.K., et al. Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med 2011;29:230-3.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Garcia MK, et al. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol 2014;7:41.

  BACKGROUND

• Schroeder G, et al. Acupuncture for chemotherapy-induced peripheral neuropathy (CIPN): a pilot study using neurography. Acupunct Med 2012;30:4-7.

  BACKGROUND

• 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

  BACKGROUND

Results Point of Contact

• Title: Polly Niravath, M.D.
• Organization: Houston Methodist Neal Cancer Center

paniravath@houstonmethodist.org

(713) 441-9948

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 23, 2026
• First Posted: March 6, 2026
• Study Start: August 29, 2019
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)