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Back|NCT05368428Recruiting
Official Title

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

Sponsor
Emory University
Enrollment
27
Timeline
Oct 2022 → Mar 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel.
  • 2At least Common Terminology Criteria for Adverse Events (CTCAE) grade 1 CIPN in hands or feet attributed to taxane chemotherapy.
  • 3Actively undergoing paclitaxel or docetaxel with plans to continue during the two-week TENS treatment.
  • 4Age \>= 18 years
  • 5For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to starting TENS
  • 6Given 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
  • 7Female 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)
  • 8Willingness and ability of the subject to comply with scheduled visits, TENS administration plan, other study procedures, and study restrictions.
  • 9Evidence 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
  • 10Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • 11Women 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

  • 1Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement
  • 2History of epilepsy
  • 3Implanted electronic device including a cardiac pacemaker, defibrillator, pain pump etc.
  • 4Pre-existing neuropathy
  • 5Prior exposure to neurotoxic chemotherapy
  • 6Previous use of TENS for CIPN
  • 7Prisoners or an adult who is unable to consent
  • 8Pregnancy

Locations

3 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Manali Bhave, MD

Emory University/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Manali Bhave, MD

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Manali Bhave, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →