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

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05368428
Trial Phases:		Protocol IDs:	WINSHIP5501-21 (primary) NCI-2022-01726 STUDY00003705
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05368428

Summary

This early phase I trial examines transcutaneous electrical nerve stimulation (TENS) in chemotherapy induced peripheral neuropathy in patients with stage I-III breast cancer. TENS is a procedure in which mild electric currents are applied to some areas of the skin. This trial may help determine if TENS is feasible and effective for chemotherapy induced peripheral neuropathy symptoms that develop while on chemotherapy.

Objectives

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 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 daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.