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

NCT ID: NCT04367480

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2022-10-03

Brief 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.

Detailed 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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group I (Active TENS)

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

Group Type: EXPERIMENTAL

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

Wear active TENS device

Group II (Placebo TENS)

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

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DEVICE

Wear placebo TENS device

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Placebo Administration

Wear placebo TENS device

Intervention Type: DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Transcutaneous Electrical Nerve Stimulation

Wear active TENS device

Intervention Type: DEVICE

Other Intervention Names

TENS; transcutaneous electric nerve stimulation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester NCORP Research Base

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Gewandter

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Gewandter

Role: PRINCIPAL_INVESTIGATOR

University of Rochester NCORP Research Base

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2019-07566

Identifier Type: REGISTRY

Identifier Source: secondary_id

URCC19085

Identifier Type: OTHER

Identifier Source: secondary_id

URCC-19085

Identifier Type: OTHER

Identifier Source: secondary_id

URCC-19085

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA235389

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

URCC19085

Identifier Type: -

Identifier Source: org_study_id