Quell Opioid Reduction and Pain Relief in Patients With Cancer

Prostate Cancer Clinical Trial

Official title: Quell Opioid Reduction and Pain Relief in Patients With Cancer

Status Terminated

Clinical Trial Summary

To study effects the Quell device has on opioid consumption and pain relief in patients with cancer.

Clinical Trial Description

Single site, double blinded, placebo controlled randomized clinical trial. 40 subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the placebo control group. Prior to the start of this study, a Controlled Substance Utilization Review and Evaluation (CURES) reports will be acquired to establish baseline number of opioid prescriptions for each subject. Subjects will track how consistently they are using pain medications, both opioids and non-opioids, during the two weeks prior to the start of the study. They will also provide twice daily recordings of their pain intensity via a mobile application. At the end of this two-week period, each subject will be fitted with a Quell device or a sham device, including initial calibration to the subject's comfort level as described in the background section.Once the study subjects have started using the device, we will also be able to monitor and track their sleep wirelessly via the mobile application as long as they are wearing the device. Subjects will receive weekly check in's to monitor the functionality of the device and to help troubleshoot any issues with the device for the duration of subject participation in the study. These check-ins will take place in person, by phone, and or per subject's usual outpatient oncology visits. Each subject will use their device for 8 weeks, during which they will continue to track their pain, sleep and frequency of pain medication use as stated above. Study investigators will receive automated alerts via email to ensure that study are participants using their devices and that the devices are powered on at regular intervals for the duration of the study.Total duration of subject participation will be 10 weeks. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Breast Cancer
• Pain
• Prostate Cancer

• NCT number: NCT02809846
• Study type: Interventional
• Source: Scripps Translational Science Institute
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Completion date: October 2017