Using electrical stimulation to treat nerve pain in breast cancer patients undergoing chemotherapy
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
NA · Emory University · NCT05368428
This study is testing if a daily electrical stimulation treatment can help breast cancer patients dealing with nerve pain from chemotherapy feel better during their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT05368428 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the feasibility and effectiveness of transcutaneous electrical nerve stimulation (TENS) for patients with stage I-III breast cancer experiencing chemotherapy-induced peripheral neuropathy. Participants will use TENS therapy daily for two weeks to assess adherence and changes in symptoms such as pain, tingling, and numbness. The study also aims to collect data on other treatments for neuropathy and any chemotherapy dose-limiting events during the trial period. The goal is to determine if TENS can improve the quality of life for these patients while they continue their chemotherapy regimen.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage I-III breast cancer currently receiving paclitaxel or docetaxel chemotherapy and experiencing at least grade 1 peripheral neuropathy.
Not a fit: Patients who are not currently undergoing chemotherapy or those with severe neuropathy or contraindications to TENS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to alleviate nerve pain for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of TENS for neuropathy is not widely established, preliminary studies suggest potential benefits, making this approach promising yet somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
- Emory University/Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Manali Bhave, MD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Manali Bhave, MD
- Email: manali.ajay.bhave@emory.edu
- Phone: 404-778-1900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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