NeuroMetrix, Inc. and the Scripps Translational Science Institute (STSI) will host a clinical study of Quell wearable pain relief technology in patients with cancer related pain.
According to the National Cancer Institute, about 15 million Americans are living with cancer or have a history of cancer. In these patients, chronic pain is one of the most feared and challenging symptoms. Unfortunately, the prevalence of pain is over 50 percent in most forms of cancer.
Prescription opioids are the mainstay of the medical management of moderate to severe cancer pain. However, given the side effects and the stigma of opioid use, there is growing interest in alternative approaches to managing cancer related pain.
Quell utilizes neurostimulation technology to provide relief from chronic pain. The wearable device is lightweight and can be worn during the day while active, and at night while sleeping. In addition to analgesic therapy, Quell objectively tracks utilization and various health metrics including sleep and activity.
In a recent study of Quell in non-cancer chronic pain, 81 percent of participants reported improvement in their chronic pain on the Patient Global Impression of Change (PGIC) scale. In addition, 67 percent of participants reported a reduction in use of analgesics.
The STSI study is 10-week single site, double blinded, sham controlled randomized clinical trial. The study will enroll 40 adult patients who have been diagnosed with metastatic breast, prostate or colorectal cancer and who use at least one opioid medication on a daily basis.
The patients will be recruited from the Scripps Cancer Center in Hillcrest, which serves central San Diego and is a cornerstone fellowship and research site for both palliative care and oncology. The primary endpoint is a reduction in daily opioid use assessed at weeks 2, 4, 6, 8 and 10 of the study.
A 20 percent change in opioid consumption will be deemed clinically relevant. That primary end point was chosen to provide a novel way for patients with cancer to have optimal pain control while reducing their overall opioid use.
The study will also examine the potential benefits of Quell as a digital health intervention. The device integrates with a smartphone app that includes electronic pain tracking and provides objective feedback to the subject about their therapy utilization and sleep.
Earlier this month, NeuroMetrix submitted a CE technical file application for the Quell pain management device seeking certification in the European Union as a class IIa medical device.