About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Scrambler Therapy
- Sham/No Intervention
Treatment groups
Sponsors and collaborators
Case Comprehensive Cancer Center
Lead sponsor
VelaSano
Collaborator