Scrambler Therapy for chemotherapy-related nerve pain (CIPN).

A Randomized, Single-Blind, Sham-Controlled Study of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

Researchers will try Scrambler Therapy, a non-drug electrical treatment, to reduce pain and numbness in people with long-lasting chemotherapy-induced peripheral neuropathy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Case Comprehensive Cancer Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07219472 on ClinicalTrials.gov

What this trial studies

Adults with persistent CIPN receive up to ten daily one-hour sessions of Scrambler Therapy delivered through adhesive electrodes placed near areas of pain, tingling, or numbness. Some participants may be assigned to active Scrambler Therapy while others receive a sham or no-intervention control to compare effects. The study measures changes in neuropathic pain intensity, related symptoms, function, and quality of life. Treatment may stop early if participants no longer report neuropathic pain.

Who should consider this trial

Good fit: Ideal candidates are adults with CIPN symptoms for at least three months, moderate pain (≥4/10), at least three months since their last neurotoxic chemotherapy dose, able to attend daily treatments, and able to give informed consent.

Not a fit: People who are pregnant or nursing, have implanted electronic medical devices, recent ischemic heart disease, a history of seizures, or who expect imminent further neurotoxic chemotherapy may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, Scrambler Therapy could reduce CIPN pain and numbness and improve daily function without adding systemic medications.

How similar studies have performed: Small prior studies and case series have reported positive effects of Scrambler Therapy for neuropathic pain and the device has FDA clearance, but larger randomized trials are limited.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Cleveland, Ohio

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

Study contacts

• Principal investigator: Laura Shoemaker, DO, MS, FAAHPM — Case Comprehensive Cancer Center, Cleveland Clinic
• Study coordinator: Laura Shoemaker, DO, MS, FAAHPM

Conditions: Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Scrambler therapy