Quell Opioid Reduction and Pain Relief in Patients With Cancer

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

Detailed Description
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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.

Official Title
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Quell Opioid Reduction and Pain Relief in Patients With Cancer

Conditions
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Pain, Metastatic Breast Cancer, Prostate Cancer, Colorectal Cancer

Intervention / Treatment
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* Device: Quell
* Device: Sham Quell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female greater than or equal to 18 year of age at visit one. Documented diagnosis of metastatic breast, prostate or colorectal cancer with a prognosis of 6 month or greater as determined by the primary oncologist. 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. Subject speaks and reads English fluently. Subject able to understand and grant informed consent. Live in an area with cellular data connectivity available as provided by the subject. Documented adherence with clinic follow up visits per medical records. Subject using at least one opioid medication on a daily basis. Exclusion Criteria: Subject has a cardiac pacemaker, implanted defibrillator or other implanted electronic device. Inability to complete subjective data as required; e.g. on mobile application and questionnaires. Does not live in an area with suitable cellular data connectivity. Has infrequent scheduled clinic visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quell Device<br>Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia. | Device: Quell<br> <br> |
| Sham Comparator: Sham Quell Device<br>Identical to Active Comparator, but provides sub-therapeutic electronic stimulation. | Device: Sham Quell<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | The primary end point of this study was the difference in the change in daily opioid use between the active device group and the sham device group, assessed at weeks 2, 4, 6, 8, and 10 of the study as recorded by the subject in their analgesia diary. Participants documented which medication was taken, how much, and at what time. Dose and type of opioid pain medication was converted to morphine milliequivalents (MME) using conversion factors published by the Centers for Medicare and Medicaid Services (CMS)and combined as a daily dose for each day in a subject's analgesia journal. | Weeks: 2,4,6,8,10 |