Status:
NOT_YET_RECRUITING
Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
VelaSano
Conditions:
Chemotherapy-induced Peripheral Neuropathy
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, particu...
Detailed Description
Neuropathy is damage or disease affecting the somatosensory nervous system. It can result in pain, numbness and other feelings of tingling or burning on the skin. Neuropathic pain often does not go aw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07219472
Start Date
December 1 2025
End Date
December 1 2027
Last Update
October 21 2025
Active Locations (1)
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1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States, 44195