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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
Undergo TENS
Emory University Hospital Midtown
Atlanta, Georgia, United States
RECRUITINGEmory University/Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGEmory Saint Joseph's Hospital
Atlanta, Georgia, United States
NOT_YET_RECRUITINGEvaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Adherence for each trial participant will be calculated by summing the number of one-hour TENS sessions completed and dividing by 14 total treatments. Adherence for the cohort will be summarized descriptively using descriptive statistics.
Time frame: Up to 2 weeks
Change in Patient Reported Outcomes Measurement Information System 29 score
Change in Patient Reported Outcomes Measurement Information System 29 score at two and six weeks compared to baseline * Physical Function scored on a scale from "without any difficulty" (maximum value) to "unable to do" (minimum value) * Anxiety scored on a scale from "always" (maximum value) to "never" (minimum value) * Depression scored on a scale from "always"(maximum value) to "never" (minimum value) * Fatigue scored on a scale of "very much" (maximum value) to "not at all" (minimum value) * Sleep Disturbance scored on a scale from "very good" (maximum value) to "very poor" (minimum value) * Ability to Participate in Social Roles and Activities" scored on a scale from "never" (maximum value) to "always" (minimum value) * Pain Interference scored on a scale from "very much" (maximum value) to "not at all" (minimum value) * Pain Intensity scored on a scale of 0-10, where "10" is the maximum value and "0" is the minimum value.
Time frame: At baseline and 2 and 6 weeks
Change in Monofilament Testing
Testing at two and six weeks compared to baseline.
Time frame: At baseline and 2 and 6 weeks
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