Actively Recruiting
Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
Led by Case Comprehensive Cancer Center · Updated on 2026-04-13
90
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
V
VelaSano
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.
CONDITIONS
Official Title
Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with chemotherapy-induced peripheral neuropathy pain lasting at least three months
- At least three months since last dose of neurotoxic cancer-directed therapy
- No planned neurotoxic cancer therapy for at least five months after enrollment
- Pain severity of 4 or higher on a 0-10 scale during the past seven days
- Life expectancy greater than six months
- Able to complete questionnaires independently or with help
- Able to provide written informed consent
- ECOG Performance Status score of 2 or higher
You will not qualify if you...
- Pregnant or nursing individuals
- Having implanted drug delivery systems, electronic medical devices, life-supporting devices, or medical monitoring devices
- History of heart attack or ischemic heart disease within six months before enrollment
- History of epilepsy, brain damage causing seizures, or using anticonvulsants for seizures
- Skin conditions like open sores preventing electrode placement
- Unable or unwilling to stop gabapentin or pregabalin before starting Scrambler Therapy
- History of symptomatic peripheral neuropathy before chemotherapy
- Prior treatment with Scrambler Therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
L
Laura Shoemaker, DO, MS, FAAHPM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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