Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer

NCT ID: NCT05368428

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2027-03-31

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks.

SECONDARY OBJECTIVES:

I. To evaluate the change in patient reported outcome (PRO) measures of symptoms (e.g. pain, tingling, numbness) and functional impairment.

II. To evaluate the change in objective measures of neuropathy over the study period through bedside monofilament testing.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To collect data on the type and use frequency of non-TENS chemotherapy-induced peripheral neuropathy (CIPN) treatments (e.g. neuropathic agents and doses) both at baseline and over the duration of the trial (six weeks).

II. To measure the number of chemotherapy dose-limiting events (dose reductions, delays, discontinuations) over the duration of the trial.

OUTLINE:

Patients undergo TENS therapy at home daily over 1 hour for 14 days in the absence of unacceptable toxicity.

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; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Chemotherapy-Induced Peripheral Neuropathy; Early Stage Breast Carcinoma; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (TENS)

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

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: OTHER

Undergo TENS

Interventions

Transcutaneous Electrical Nerve Stimulation

Undergo TENS

Intervention Type: OTHER

Other Intervention Names

TENS; transcutaneous electric nerve stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Manali Bhave

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manali Bhave, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Manali Bhave, MD

Role: CONTACT

manali.ajay.bhave@emory.edu

404-778-1900

Facility Contacts

Ashley Trumbull

Role: primary

ashley.lynn.trumbull@emory.edu

404-778-4389

L.

Role: backup

Ashley Trumbull

Role: primary

ashley.lynn.trumbull@emory.edu

404-778-4389

Ashley Trumbull

Role: primary

ashley.lynn.trumbull@emory.edu

404-778-4389

Other Identifiers

NCI-2022-01726

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00003705

Identifier Type: OTHER

Identifier Source: secondary_id

WINSHIP5501-21

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003705

Identifier Type: -

Identifier Source: org_study_id