Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT07219472

Run by

Case Comprehensive Cancer Center

People needed

90

Starts

2026-03-27

Expected to finish

2027-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
• At least three months from the last dose of neurotoxic cancer-directed drug
• No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
• Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
• > Six-month life expectancy
• Able to complete questionnaires by themselves or with assistance
• Able to provide informed written consent
• ECOG Performance Status score ≥ two
• Not currently enrolled in another research study for pain or neuropathy

You may not qualify if…

• Pregnant or nursing
• An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
• History of myocardial infarction or ischemic heart disease within six months of trial enrollment
• History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
• Skin conditions such as open sores that will prevent proper application of electrodes
• Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST
• History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy
• Prior treatment with Scrambler Therapy
• The presence of chronic regional pain syndrome (CRPS) in the scrambler therapy treatment area.

Where it is running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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