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

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Breast Neoplasms
  • Chemotherapy-Induced Peripheral Neuropathy
  • Early Stage Breast Carcinoma
  • Peripheral Nervous System Diseases
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
Clinical Trial Details
NCT number NCT05368428
Study type Interventional
Source Emory University
Contact Manali Bhave, MD
Phone 404-778-1900
Email manali.ajay.bhave@emory.edu
Status Recruiting
Phase N/A
Start date October 19, 2022
Completion date March 31, 2025
View Details
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