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
Emory University
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks. SECONDARY OBJECTIVES: I. To evaluate the change in patient reported outcome (PRO) measures of symptoms (e.g. pain, tingling, numbness) and functional impairment. II. To evaluate the change in objective measures of neuropathy over the study period through bedside monofilament testing. TERTIARY/EXPLORATORY OBJECTIVES: I. To collect data on the type and use frequency of non-TENS chemotherapy-induced peripheral neuropathy (CIP…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 uterin…
Interventions
- OtherTranscutaneous Electrical Nerve Stimulation
Undergo TENS
Locations (3)
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University/Winship Cancer InstituteAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia