Status:
COMPLETED
Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
University of Rochester NCORP Research Base
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 perip...
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 confirma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04367480
Start Date
September 10 2020
End Date
October 3 2022
Last Update
September 8 2023
Active Locations (15)
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1
Christiana Health Care System
Newark, Delaware, United States, 19713
2
Lee Memorial Health System
Fort Myers, Florida, United States, 33905
3
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
4
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503