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Could a simple TENS device ease chemo nerve pain?

NCT ID NCT05368428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tested whether a TENS device, which sends mild electrical pulses to the skin, can help relieve nerve pain caused by chemotherapy in early-stage breast cancer patients. The study enrolled 17 people who were having taxane chemotherapy and had at least mild nerve pain in their hands or feet. Participants used TENS daily for two weeks, and researchers measured how well they stuck with the treatment and whether their symptoms improved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous Electrical Nerve Stimulation (TENS)
What this could lead to
If it works, TENS could offer a drug-free way to ease nerve pain caused by chemotherapy in breast cancer patients.
What could go wrong
This was a very small, early trial that was terminated early, so results are limited. TENS may not work for everyone and requires daily use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

17 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel. * At least Common Terminology Criteria for Adverse Events (CTCAE) grade 1 CIPN in hands or feet attributed to taxane chemotherapy. * Actively undergoing paclitaxel or docetaxel with plans to continue during the two-week TENS treatment. * Age \>= 18 years * For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to starting TENS * Given the potential concern that TENS could induce uterine contractions or interfere with fetal cardiac conduction, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy * Female of childbearing potential (FCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of TENS treatment. Should a woman become pregnant or suspect she is pregnant during the two weeks of TENS, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Willingness and ability of the subject to comply with scheduled visits, TENS administration plan, other study procedures, and study restrictions. * Evidence of a personally signed informed consent indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation * Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up * Women of child bearing potential (FCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Exclusion Criteria: * Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement * History of epilepsy * Implanted electronic device including a cardiac pacemaker, defibrillator, pain pump etc. * Pre-existing neuropathy * Prior exposure to neurotoxic chemotherapy * Previous use of TENS for CIPN * Prisoners or an adult who is unable to consent * Pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

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