IRB Study Number 25-785
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Taussig Cancer Institute
Description
Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of patients who have received chemotherapy for treatment of cancer. These symptoms can lead to physical suffering, limitation of function, and a decreased quality of life (QOL). Scrambler Therapy (ST) is an FDA-approved electro-analgesic device that has shown promise in the treatment of CIPN. ST’s innovative approach differs from other electro-analgesic devices through the targeting surface C-fibers to transmit painless information which acts to remodulate (“or scramble”) the perceived pain.
Cleveland Clinic’s Department of Palliative and Supportive Care acquired an ST device, the first in the institution, in 2022. We performed a retrospective pilot study with 12 patients treated with ST for chronic neuropathic symptoms from November 2022 to June 2023, which demonstrated a 58% success rate. As a follow-up study and with a grant from VeloSano, this study aims to: (1) determine the effect of a standard course of ST on patient-reported pain score in patients with CIPN compared to a control group receiving sham treatment; (2) characterize the effect of ST therapy patient-reported neuropathic, non-pain sensations, functional status, overall QOL, and patient-perceived treatment efficacy; and (3) determine the difference in patient reported analgesic use (including opioids) for CIPN following standard course of ST versus sham treatment.
Outcomes will be tracked for 12 months, thus offering insight into both the short and long-term effects of ST. If positive, this result would add to the small body of evidence demonstrating ST, as an alternative to pharmacologic therapy for CIPN. Future research opportunities include assessing the efficacy of ST administered concurrently with chemotherapy, investigating if neurotoxicity can be mitigated or even prevented
OBJECTIVES
2.1 Determine the effect of a standard course of ST on patient-reported pain score in patients with CIPN compared to a control group receiving sham treatment.
We hypothesize that patients in the ST group will have a higher average difference in pain scores from baseline to end of treatment compared to patients in the control group.
2.2 Characterize the effect of ST therapy on:
Patient-reported non-pain neuropathic symptoms including numbness, tingling, cold, burning, stiffness, swelling, and pruritic sensations
Functional status
Overall QOL
Patient-perceived treatment efficacy
We hypothesize that patients in the ST group will have a higher average difference in non-pain neuropathic symptom scores, improved functional status, improved QOL, and improved patient-perceived treatment efficacy compared to patients in the control group.
2.3 Determine the difference in patient reported analgesic use (including opioids) for CIPN following standard course of ST versus sham treatment.
We hypothesize greater reduction in reported analgesic use for CIPN among patients in the ST group compared to patients in the control group.
Inclusion Criteria
• Adults with CIPN-related pain for at least three months duration, and for which the patient 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
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.
