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Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy

NCT04367480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-09-08

Study results available
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Summary

This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.

Conditions

  • Chemotherapy-Induced Peripheral Neuropathy

Interventions

DEVICE

Placebo Administration

Wear placebo TENS device

OTHER

Questionnaire Administration

Ancillary studies

DEVICE

Transcutaneous Electrical Nerve Stimulation

Wear active TENS device

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Rochester NCORP Research Base

    lead OTHER

Principal Investigators

  • Jennifer Gewandter · University of Rochester NCORP Research Base

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2022-10-03
Completion
2022-10-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367480 on ClinicalTrials.gov