Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial (URCC 19085 TENS)

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• 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

A patient will not be eligible for participation in this study if any of the following criteria apply.

• 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

To learn more, visit ClinicalTrials.Gov

Study Type

N/A

Principal Investigator(s)

James Bearden III, MD, FACP

Sponsor(s)

University of Rochester NCORP Research Base