Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial (URCC 19085 TENS)
Testing the Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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.
Key Inclusion Criteria
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
Key Exclusion Criteria
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
James Bearden III, MD, FACP
University of Rochester NCORP Research Base