Clinical trial NCT02809846: Quell Opioid Reduction and Pain Relief in Patients With Cancer
Official title: Quell Opioid Reduction and Pain Relief in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Metastatic Breast Cancer
Prostate Cancer
Colorectal Cancer
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: NeuroMetrix, Inc.
First posted: 2016-06-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female greater than or equal to 18 year of age at visit one.
2. Documented diagnosis of metastatic breast, prostate or colorectal cancer with a prognosis of 6 month or greater as determined by the primary oncologist.
3. Visual evidence that subject owns a smart phone and is able to use basic mobile applications such as downloading an app, opening the app, and performing one simple task within the app.
4. Subject speaks and reads English fluently.
5. Subject able to understand and grant informed consent.
6. Live in an area with cellular data connectivity available as provided by the subject.
7. Documented adherence with clinic follow up visits per medical records.
8. Subject using at least one opioid medication on a daily basis.

Exclusion Criteria:

1. Subject has a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
2. Inability to complete subjective data as required; e.g. on mobile application and questionnaires.
3. Does not live in an area with suitable cellular data connectivity.
4. Has infrequent scheduled clinic visits.

Primary outcomes:
measure: Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary.
timeFrame: Weeks: 2,4,6,8,10
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: Scripps
name: Lase Ajayi, MD
role: PRINCIPAL_INVESTIGATOR
References: