Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

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, 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.

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 away for a long time, which can negatively impact quality of life. Even though neuropathic pain comes from the nervous system, it is often managed with medications. In recent years, Scrambler Therapy (ST) has come up as a way to treat neuropathic pain that does not use medications. ST was approved by the FDA in 2009 to treat neuropathic pain. It works by replacing or overriding pain signals and rewires the way that people may perceive pain. It was originally designed to treat cancer pain. A standard course of ST consists of ten daily sessions over two consecutive weeks. Treatment may stop early if participants no longer report feeling neuropathic pain. Previous research on the effects of ST for neuropathic pain have shown positive findings with very few participants reporting negative side effects of ST treatment. However, there are some limitations of ST, including the time and cost of the treatment, limited availability of ST, and the necessary skills needed to administer it. ST is a promising solution to pain caused by CIPN. CIPN occurs in 30-40% of people treated with chemotherapy. CIPN can sometimes cause interruptions in cancer treatment and negatively impact quality of life. The amount of people with CIPN may also rise as more people with cancer live longer. Due to this, it is important to explore ST as a treatment for CIPN. This study aims to investigate the short-term and long-term impacts of ST as an alternative to medication treatments for CIPN.

Eligibility Criteria

Interventions