Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
5 other identifiers
interventional
151
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2022
CompletedResults Posted
Study results publicly available
September 8, 2023
CompletedSeptember 8, 2023
August 1, 2023
2.1 years
April 21, 2020
August 9, 2023
August 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
6 weeks after the start of intervention
Secondary Outcomes (5)
Effect of TENS on Hot/Burning Pain
6 weeks after the start of intervention
Effect of TENS on Sharp/Shooting Pain
6 weeks after the start of intervention
Effect of TENS on Numbness
6 weeks after the start of intervention
Effect of TENS on Tingling
6 weeks after the start of intervention
Effect of TENS on Cramping
6 weeks after the start of intervention
Study Arms (2)
Group I (Active TENS)
EXPERIMENTALPatients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Group II (Placebo TENS)
PLACEBO COMPARATORPatients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Interventions
Wear active TENS device
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Christiana Health Care System
Newark, Delaware, 19713, United States
Lee Memorial Health System
Fort Myers, Florida, 33905, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
St. Vincent Hospital Cancer Center at St. Mary's
Green Bay, Wisconsin, 54303, United States
Aspirus
Wausau, Wisconsin, 54401, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Gewandter, PhD
- Organization
- University of Rochester NCORP Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Gewandter
University of Rochester NCORP Research Base
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 29, 2020
Study Start
September 10, 2020
Primary Completion
October 3, 2022
Study Completion
October 3, 2022
Last Updated
September 8, 2023
Results First Posted
September 8, 2023
Record last verified: 2023-08