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.
Additional locations may be listed on ClinicalTrials.gov for NCT05368428.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital MidtownStatus: Active
Contact: Manali Bhave
Emory Saint Joseph's HospitalStatus: Active
Contact: Manali Bhave
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Manali Bhave
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorManali Bhave