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โ† Trials
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Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

RecruitingNAAges 18 Years - anyAllCase Comprehensive Cancer Center
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In plain words

What the trial is, and whether it could suit you

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 stu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ two * Not currently enrolled in another research study for pain or neuropathy 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 * The presence of chronic regional pain syndrome (CRPS) in the scrambler therapy treatment area.
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What it tests

  • Scrambler Therapy
  • Sham/No Intervention
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Where

1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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