Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07219472
Status
Recruiting
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Conditions

  • CIPN - Chemotherapy-Induced Peripheral Neuropathy
  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Scrambler Therapy — DEVICE
    Participants will attend 10 consecutive weekday 45-minute sessions of scrambler therapy.
  • Sham/No Intervention — OTHER
    Participants will be blinded as to which arm they are in (experimental vs. sham comparator), and as such, participants in the sham comparator arm will attend 10 consecutive weekday 45-minute sessions of sham scrambler therapy. In the sham comparator arm, participants will NOT receive a therapeutic level of scrambler therapy.

Study Details

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 Dates

Start date
Mar 27, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Scrambler Therapy
  • Sham Comparator: Sham Scrambler Therapy

Primary Outcome Measure

Change in participant-reported pain [ Time Frame: Baseline, end of treatment (up to 14 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Laura Shoemaker, DO, MS, FAAHPM
[email protected]
(216) 444-5193
Laura Shoemaker, DO, MS, FAAHPM (PRINCIPAL_INVESTIGATOR)

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By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OH

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