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.
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
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
Parallel
Scrambler Therapy
DeviceParticipants will attend 10 consecutive weekday 45-minute sessions of scrambler therapy.
Sham/No Intervention
Other interventionParticipants 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.
Change in participant-reported pain
Participant-reported pain is measured by the Severity of Neuropathic Symptoms, in which participants rank their pain on a scale of 0 (Not at All) to 10 (Severe). Higher scores indicate greater pain symptoms.
Change in participant-reported non-pain neuropathic symptoms
Participant-reported non-pain neuropathic symptoms are measured by the Severity of Neuropathic Symptoms, in which participants rank their symptoms on a scale of 0 (Not at All) to 10 (Severe) for the following areas: numbness, tingling, cold sensation, warm sensation, stiffness, swelling, and pruritus. Higher scores indicate greater symptoms.
Change in functional status
Functional status is measured by the Functional Well-Being subscale of the Functional Assessment of Cancer Therapy - General (FACT-G) (version 4). This subscale contains 7 items, which participants will rank their functional status for each item on a 5-point scale of 0 (Not at all) to 4 (Very much). Lower scores indicate greater functional status.
Change in quality of life
Quality of life is measured by the Functional Assessment of Cancer Therapy - General (FACT-G) (version 4). It is a 27-item questionnaire with four subscales (physical well-being, social/family well-being, emotional well-being, and functional well-being). Participants answer questions on a 5-point scale from 0 (Not all all) to 4 (Very much). Lower scores indicate greater quality of life.
Change in participant-perceived treatment efficacy
Participant-perceived treatment efficacy is measured by the Patient Global Impression of Change, which is a single-item measure. Participants rank their belief about treatment efficacy on a 7-point scale from "Very much improved" to "Very much worse." Scores in the "improved" qualitative items indicate a greater perceived treatment efficacy.
Change in participant-reported analgesic use for CIPN
Analgesic use will be measured by participant report of each type of and count of medication used in an attempt to lessen their neuropathy.
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
VelaSano
Collaborator
