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Not recruiting

TENS

Sponsor:

Emory University

Code:

NCT05368428

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IA Breast Cancer AJCC v8

Anatomic Stage IB Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Electrical Nerve Stimulation

Study Details

Brief summary:

This phase II trial examines transcutaneous electrical nerve stimulation (TENS) in patients with stage I-III breast cancer with chemotherapy induced peripheral neuropathy. TENS is a procedure in which mild electric currents are applied to some areas of the skin to potentially improve neuropathy. This trial may help determine if TENS is feasible and effective for the treatment of peripheral neuropathy symptoms while on chemotherapy.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IA Breast Cancer AJCC v8

Anatomic Stage IB Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Study ID

NCT05368428

Start date

Oct 19, 2022

Status verified date

May, 2026

Completion date

Nov 18, 2025

Primary completion date

Nov 18, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

17 participants

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (TENS)

Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.

Interventions

Transcutaneous Electrical Nerve Stimulation

Undergo TENS

Primary outcome measure

  • Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

More Information

Sponsor

Emory University

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-18.