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

Last updated: August 16, 2023
Sponsor: University of Rochester NCORP Research Base
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

Transcutaneous Electrical Nerve Stimulation

Placebo Administration

Questionnaire Administration

Clinical Study ID

NCT04367480
URCC19085
R21CA235389
NCI-2019-07566
UG1CA189961
URCC19085
URCC-19085
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomibat least 3 months prior to registration
  • Have a clinical diagnosis of CIPN from their physician or physician designee based onthe following criteria: bilateral (i.e., present on both sides of the body), abnormalsensory 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) asat 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 - weekrecall 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 dosagesof any current analgesic medications (except acetaminophen [Tylenol] or non-steroidalanti-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 thatcan be used to access the TENS device's application (App) and ability to connect tothe internet on a daily basis during the trial

Exclusion

Exclusion Criteria:

  • Have pre-existing neuropathy of any cause documented in their medical record prior tothe start of chemotherapy or respond "yes" to the question "Did you have frequentnumbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feetbefore you started your chemotherapy?"
  • Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side ofthe 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 causeneuropathy in a significant portion of patients
  • Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVTwith resolution of symptoms is acceptable for enrollment)
  • Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes lessthan 15 seconds to rebound)
  • Have started a new prescription pain medication or altered dosages of a prescriptionpain 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 authorizedrepresentative or health care proxy)
  • Be pregnant or planning to get pregnant before expected completion of the study

Study Design

Total Participants: 151
Treatment Group(s): 3
Primary Treatment: Transcutaneous Electrical Nerve Stimulation
Phase:
Study Start date:
September 10, 2020
Estimated Completion Date:
October 03, 2022

Study Description

PRIMARY OBJECTIVE:

I. Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 [EORTC-CIPN20]) to inform the design of a phase III confirmatory trial.

SECONDARY OBJECTIVES:

I. Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale [NRS]).

II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation [CPM] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.

EXPLORATORY OBJECTIVES:

I. Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression.

II. Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.

GROUP II: Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.

Connect with a study center

  • Christiana Health Care System

    Newark, Delaware 19713
    United States

    Site Not Available

  • Beebe Health Campus

    Rehoboth Beach, Delaware 19971
    United States

    Site Not Available

  • Lee Memorial Health System

    Fort Myers, Florida 33905
    United States

    Site Not Available

  • Hawaii Cancer Care - Savio

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Metro Health Hospital

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Missouri Baptist Medical Center

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina 29341
    United States

    Site Not Available

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Spartanburg Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • MGC Hematology Oncology-Union

    Union, South Carolina 29379
    United States

    Site Not Available

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • St. Vincent Hospital Cancer Center at St. Mary's

    Green Bay, Wisconsin 54303
    United States

    Site Not Available

  • Aspirus

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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