Colorectal Cancer, Metastatic Breast Cancer, Pain, Prostate Cancer
Conditions
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.
Interventions
DEVICEQuell
DEVICESham Quell
Sponsors
NeuroMetrix, Inc.
Scripps Translational Science Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | 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. |
Countries
United States
Participant flow
Recruitment details
Study was conducted at the Scripps Mercy Oncology Clinic in San Diego California. Enrollment began on Wednesday 7/5/216. The last participant completed on 7/27/17 . The trial was terminated before reaching the projected sample size because of unanticipated difficulties in the recruitment and retention of individuals with targeted conditions.
Participants by arm
| Arm | Count |
|---|---|
| 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.
For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz.
Quell | 17 |
| Sham Quell Device Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz
Sham Quell | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Quell Device | Sham Quell Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 11 Participants | 14 Participants | 25 Participants |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 4 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
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.
Time frame: Weeks: 2,4,6,8,10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quell Device | Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | Week 0 (Baseline) | 51.1 MME | Standard Deviation 40.8 |
| Quell Device | Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | Week 10 | 27.0 MME | Standard Deviation 33.7 |
| Sham Quell Device | Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | Week 0 (Baseline) | 41.3 MME | Standard Deviation 46.7 |
| Sham Quell Device | Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. | Week 10 | 38.5 MME | Standard Deviation 15.6 |
Comparison: Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05p-value: <0.05Mixed Models Analysis