Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
Single-Institution Trial Investigating the Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in Taxane Induced Peripheral Neuropathy (CIPN) in Patients With Early Stage Breast Cancer
4 other identifiers
interventional
27
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedApril 24, 2025
April 1, 2025
3.3 years
May 5, 2022
April 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Adherence for each trial participant will be calculated by summing the number of one-hour TENS sessions completed and dividing by 14 total treatments. Adherence for the cohort will be summarized descriptively using descriptive statistics.
Up to 2 weeks
Secondary Outcomes (2)
Change in Patient Reported Outcomes Measurement Information System 29 score
At baseline and 2 and 6 weeks
Change in Monofilament Testing
At baseline and 2 and 6 weeks
Study Arms (1)
Supportive Care (TENS)
EXPERIMENTALPatients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo TENS
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manali Bhave, MD
Emory University Hospital/Winship Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2022
First Posted
May 10, 2022
Study Start
October 19, 2022
Primary Completion
January 23, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
April 24, 2025
Record last verified: 2025-04