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

Launched by EMORY UNIVERSITY · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Transcutaneous Electrical Nerve Stimulation (TENS) for patients with early-stage breast cancer who are experiencing nerve pain due to chemotherapy. TENS involves using mild electric currents applied to the skin, which may help relieve the symptoms of nerve pain, known as chemotherapy-induced peripheral neuropathy (CIPN). The trial is looking to see if TENS is a safe and effective way to improve these symptoms for patients receiving specific chemotherapy drugs, paclitaxel or docetaxel.

To be eligible for the trial, participants must be adults aged 18 or older with stage I-III breast cancer currently undergoing treatment with paclitaxel or docetaxel. They should be experiencing at least mild nerve pain in their hands or feet related to their chemotherapy. Participants can expect to receive TENS treatment for two weeks, while continuing their chemotherapy. It's important to note that women who can become pregnant must have a negative pregnancy test before starting the trial and agree to use birth control during the study. This trial is currently recruiting participants, and those who join will be closely monitored throughout the process.

Gender

ALL

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