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Trial record 1 of 2 for:    Quell | cancer
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Quell Opioid Reduction and Pain Relief in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809846
Recruitment Status : Terminated (Unable to recruit enough participants.)
First Posted : June 22, 2016
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
NeuroMetrix, Inc.
Information provided by (Responsible Party):
Scripps Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Pain Metastatic Breast Cancer Prostate Cancer Colorectal Cancer Device: Quell Device: Sham Quell Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Quell Opioid Reduction and Pain Relief in Patients With Cancer
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Quell Device
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
Sham Comparator: Sham Quell Device
Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.
Device: Sham Quell



Primary Outcome Measures :
  1. Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. [ Time Frame: Weeks: 2,4,6,8,10 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809846


Locations
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United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
NeuroMetrix, Inc.
Investigators
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Principal Investigator: Lase Ajayi, MD Scripps
  Study Documents (Full-Text)

Documents provided by Scripps Translational Science Institute:
Study Protocol  [PDF] December 16, 2016
Statistical Analysis Plan  [PDF] January 17, 2019

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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02809846    
Other Study ID Numbers: IRB-16-6815
First Posted: June 22, 2016    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases