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

April 29, 2026 updated by: The Methodist Hospital Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
Time Frame: 5 Months
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
5 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Neuropathic Pain After a 10-treatment EA Program
Time Frame: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
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
Time Frame: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Intraepidermal Nerve Fiber (IENF) Density After a 10-treatment EA Program
Time Frame: 5 Months
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
Time Frame: 5 Months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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