PainNCT02809846
Quell Opioid Reduction and Pain Relief in Patients With Cancer
A study testing Quell in people with Pain and Metastatic Breast Cancer, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
To study effects the Quell device has on opioid consumption and pain relief in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Metastatic Breast Cancer, Prostate Cancer
- What is being tested?
- Quell
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
To study effects the Quell device has on opioid consumption and pain relief in patients with cancer.
Read the 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.
- Conditions
- Pain, Metastatic Breast Cancer, Prostate Cancer, Colorectal Cancer
- Being tested
- Quell, Sham Quell
- Medical subject headings
- Pain, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuellDevice
Sham QuellDevice
| Study group | Role | What they receive |
|---|---|---|
| Quell Device | Active comparator | 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. Receives: Device: Quell |
| Sham Quell Device | Sham comparator | Identical to Active Comparator, but provides sub-therapeutic electronic stimulation. Receives: Device: Sham Quell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks: 2,4,6,8,10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionOct 2017
Why it stopped: Unable to recruit enough participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Responsible party
- Sponsor
- Investigators
- Lase Ajayi, MD, Principal investigator, Scripps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809846
- Sponsor's protocol ID
- IRB-16-6815
- Status last verified
- Apr 2019
- First submitted
- 20 Jun 2016
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quell Opioid Reduction and Pain Relief in Patients With Cancer
- ClinicalTrials.gov ID
- NCT02809846
- Acronym / sponsor ID
- IRB-16-6815
- Conditions
- Pain, Metastatic Breast Cancer, Prostate Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough participants.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quell Device | Active comparator | Device: QuellQuell 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. |
| Sham Quell Device | Sham comparator | Device: Sham QuellIdentical to Active Comparator, but provides sub-therapeutic electronic stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quell | Device | Quell Device |
| Sham Quell | Device | Sham Quell Device |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lase Ajayi, MD principal investigator
Scripps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quell in people with Pain and Metastatic Breast Cancer, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. (time frame: Weeks: 2,4,6,8,10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.