Phase
Condition
Neurologic Disorders
Treatment
Transcutaneous Electrical Nerve Stimulation
Placebo Administration
Questionnaire Administration
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomibat least 3 months prior to registration
- Have a clinical diagnosis of CIPN from their physician or physician designee based onthe following criteria: bilateral (i.e., present on both sides of the body), abnormalsensory 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) asat 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 - weekrecall 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 dosagesof any current analgesic medications (except acetaminophen [Tylenol] or non-steroidalanti-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 thatcan be used to access the TENS device's application (App) and ability to connect tothe internet on a daily basis during the trial
Exclusion
Exclusion Criteria:
- Have pre-existing neuropathy of any cause documented in their medical record prior tothe start of chemotherapy or respond "yes" to the question "Did you have frequentnumbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feetbefore you started your chemotherapy?"
- Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side ofthe 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 causeneuropathy in a significant portion of patients
- Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVTwith resolution of symptoms is acceptable for enrollment)
- Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes lessthan 15 seconds to rebound)
- Have started a new prescription pain medication or altered dosages of a prescriptionpain 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 authorizedrepresentative or health care proxy)
- Be pregnant or planning to get pregnant before expected completion of the study
Study Design
Study Description
Connect with a study center
Christiana Health Care System
Newark, Delaware 19713
United StatesSite Not Available
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United StatesSite Not Available
Lee Memorial Health System
Fort Myers, Florida 33905
United StatesSite Not Available
Hawaii Cancer Care - Savio
'Aiea, Hawaii 96701
United StatesSite Not Available
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United StatesSite Not Available
Decatur Memorial Hospital
Decatur, Illinois 62526
United StatesSite Not Available
Springfield Clinic
Springfield, Illinois 62702
United StatesSite Not Available
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
United StatesSite Not Available
Metro Health Hospital
Wyoming, Michigan 49519
United StatesSite Not Available
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United StatesSite Not Available
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
United StatesSite Not Available
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
United StatesSite Not Available
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United StatesSite Not Available
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United StatesSite Not Available
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
United StatesSite Not Available
Spartanburg Medical Center
Spartanburg, South Carolina 29303
United StatesSite Not Available
MGC Hematology Oncology-Union
Union, South Carolina 29379
United StatesSite Not Available
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
United StatesSite Not Available
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United StatesSite Not Available
St. Vincent Hospital Cancer Center at St. Mary's
Green Bay, Wisconsin 54303
United StatesSite Not Available
Aspirus
Wausau, Wisconsin 54401
United StatesSite Not Available

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