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

Completed · Not applicable · Has a placebo group

Conditions studied: Chemotherapy-Induced Peripheral Neuropathy

In brief

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.

Key facts

Study ID: NCT04367480
Run by: University of Rochester NCORP Research Base
People needed: 151
Starts: 2020-09-10
Expected to finish: 2022-10-03
Last updated by the study team: 2023-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomib at least 3 months prior to registration
Have a clinical diagnosis of CIPN from their physician or physician designee based on the following criteria: bilateral (i.e., present on both sides of the body), abnormal sensory symptoms in their feet or legs (e.g., hot/burning pain, sharp/shooting pain, numbness, tingling, cramping)
Report at least 1 non-painful symptom associated with CIPN in their lower limbs (e.g., tingling, burning that isn't reported as painful, numbness)
Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen [Tylenol] or non-steroidal anti-inflammatory drugs [NSAIDs] [i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)]) for the duration of the study
Be able to read English (i.e., is not illiterate, can speak English, and is not blind)
Have access to a smart phone or device with an Apple or Android operating system that can be used to access the TENS device's application (App) and ability to connect to the internet on a daily basis during the trial

You may not qualify if…

Have pre-existing neuropathy of any cause documented in their medical record prior to the start of chemotherapy or respond "yes" to the question "Did you have frequent numbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feet before you started your chemotherapy?"
Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side of the body)
Be currently using a TENS device for any other reason
Be currently taking, or have taken in the past 3 months, medications known to cause neuropathy in a significant portion of patients
Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVT with resolution of symptoms is acceptable for enrollment)
Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes less than 15 seconds to rebound)
Have started a new prescription pain medication or altered dosages of a prescription pain medication within the last 2 weeks
Have lower extremity wounds or ulcers
Have a cardiac pace maker or defibrillator
Have epilepsy
Have a leg that is too small or too large for the TENS device to fit securely
Have missing lower limbs or amputations
Have impaired decision making capacity (i.e., requires a legally authorized representative or health care proxy)
Be pregnant or planning to get pregnant before expected completion of the study

Where it is running

Christiana Health Care System — Newark, Delaware, United States
Lee Memorial Health System — Fort Myers, Florida, United States
Decatur Memorial Hospital — Decatur, Illinois, United States
Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
Metro Health Hospital — Wyoming, Michigan, United States
Gibbs Cancer Center-Gaffney — Gaffney, South Carolina, United States
Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham — Greer, South Carolina, United States
Spartanburg Medical Center — Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union — Union, South Carolina, United States
Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
St. Vincent Hospital Cancer Center at St. Mary's — Green Bay, Wisconsin, United States
Aspirus — Wausau, Wisconsin, United States

Full record on ClinicalTrials.gov

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