Spots Global Cancer Trial Database for Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer

Study Description

Brief 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.

Detailed 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 (CIPN) treatments (e.g. neuropathic agents and doses) both at baseline and over the duration of the trial (six weeks). II. To measure the number of chemotherapy dose-limiting events (dose reductions, delays, discontinuations) over the duration of the trial. OUTLINE: Patients undergo TENS therapy at home daily over 1 hour for 14 days in the absence of unacceptable toxicity.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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