Actively Recruiting
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
Led by Emory University · Updated on 2025-04-24
27
Participants Needed
3
Research Sites
232 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
- At least grade 1 chemotherapy-induced peripheral neuropathy in hands or feet from taxane chemotherapy
- Currently receiving paclitaxel or docetaxel with plans to continue during the two-week TENS treatment
- Age 18 years or older
- Negative pregnancy test within 14 days before starting TENS for females of childbearing potential
- Females of childbearing potential must agree to use effective contraception before and during TENS treatment
- Willingness and ability to follow study visits, TENS use, procedures, and restrictions
- Signed informed consent with understanding of study procedures, risks, benefits, and alternatives
- Psychological and general health adequate to complete study requirements and follow-up
- Females of childbearing potential must use contraception throughout study participation
You will not qualify if you...
- Skin wounds, skin breakdown, or swelling at TENS electrode pad sites
- History of epilepsy
- Having an implanted electronic device like a pacemaker, defibrillator, or pain pump
- Pre-existing neuropathy unrelated to chemotherapy
- Previous treatment with neurotoxic chemotherapy
- Prior use of TENS for chemotherapy-induced peripheral neuropathy
- Prisoners or adults unable to give consent
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
Research Team
M
Manali Bhave, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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