Back to resultsEmbr Thermal Device for Hot Flash Management in Prostate Cancer
Primary Purpose
Prostate Cancer, Hot Flashes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embr thermal device
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring androgen deprivation therapy, orchiectomy, prostate carcinoma, night sweats, hormone therapy
Eligibility Criteria
Inclusion Criteria:
- Have received a diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy or orchiectomy at least 1 month prior to enrollment.
- May have received prior definitive radiation therapy or surgery (>60 days prior to study).
- Have bothersome hot flashes (occurrence ≥ 28 times per week and at least moderately bothersome).
- Presence of hot flashes for >30 days prior to study entry.
- Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater).
- Willing to downloading and use the Embr thermal device companion app on their phone
- Willing to wear the Embr thermal device for 4 weeks, and charge and sync the device daily
- In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English
Exclusion Criteria:
- Planned treatment with chemotherapy and/or any medical intervention that will impact hot flashes, sleep, or other daily activities of daily life during the 4-week study.
- History of a known sleep disorder, other than insomnia (eg, obstructive sleep apnea, restless leg syndrome), or medical or psychiatric condition that affects sleep, or undergoing treatment for insomnia.
- History of cognitive impairment or dysfunction.
- Seizure history, history of recurrent falls, or known brain metastases.
- Uncontrolled intercurrent illness.
- Individuals with a second malignancy other than non-melanoma skin cancers.
- Individuals taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior.
- Individuals taking prescription sleep medications.
- Individuals who report consuming more than 7 alcoholic beverages/week and/or frequent alcohol consumption within 2 hours prior to bed.
Sites / Locations
- Embr Labs (Remote study site)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Embr thermal device
Arm Description
Use of the Embr thermal device
Outcomes
Primary Outcome Measures
Embr thermal device usage, average number of minutes per day per participant
Number of minutes logged with the Embr device.
Embr thermal device usage, average number of sessions per day per participant
Number of sessions logged with the Embr device.
Secondary Outcome Measures
Hot Flash Related Daily Interference Scale (HFRDIS), change in score
The Hot Flash Related Daily Interference Scale is a 10-item self-report measure that assesses the interference on several aspects of functioning associated with hot flashes. This valid and reliable self-report measure is widely used in prostate cancer research. Scores range from 0 to 100, with higher scores indicating greater interference.
PROMIS Sleep Disturbance short form 4a, change in score
The PROMIS Sleep Disturbance SF 4a is a 4-item self report measure of perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
PROMIS Sleep-Related Impairment short form 8a, change in score
The PROMIS Sleep-Related Impairment SF 8a is an 8-item self reported measure of perceived alertness, sleepiness, and tiredness during usual waking hours. The 8 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 8 (good quality) to 40 (poor quality).
Epworth sleepiness scale, change in score
The Epworth Sleepiness Scale is a widely used measure of daytime sleepiness. Scores range from 0 to 24; scores of greater than 10 indicate excessive daytime sleepiness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04892914
Brief Title
Embr Thermal Device for Hot Flash Management in Prostate Cancer
Official Title
Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Embr Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.
Detailed Description
The Embr thermal device is a smart device that is worn on the inside of the wrist. It is about the size of a smart watch. The Embr thermal device produces cooling or warming temperature sensations that make some people feel slightly cooler or warmer. This objective of this study is to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment. The study will take place over 4 weeks. The primary outcome is feasibility of the Embr thermal device in men with prostate cancer. Secondary outcomes include preliminary efficacy of the device, which will include the change in hot flash interference sleep measures (sleep impairment and fatigue). This is a remote study--all study assessments will be completed electronically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Hot Flashes
Keywords
androgen deprivation therapy, orchiectomy, prostate carcinoma, night sweats, hormone therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Embr thermal device
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Embr thermal device
Arm Type
Experimental
Arm Description
Use of the Embr thermal device
Intervention Type
Device
Intervention Name(s)
Embr thermal device
Intervention Description
Participants use the Embr thermal device for 4 weeks
Primary Outcome Measure Information:
Title
Embr thermal device usage, average number of minutes per day per participant
Description
Number of minutes logged with the Embr device.
Time Frame
Weeks 0 to 4
Title
Embr thermal device usage, average number of sessions per day per participant
Description
Number of sessions logged with the Embr device.
Time Frame
Weeks 0 to 4
Secondary Outcome Measure Information:
Title
Hot Flash Related Daily Interference Scale (HFRDIS), change in score
Description
The Hot Flash Related Daily Interference Scale is a 10-item self-report measure that assesses the interference on several aspects of functioning associated with hot flashes. This valid and reliable self-report measure is widely used in prostate cancer research. Scores range from 0 to 100, with higher scores indicating greater interference.
Time Frame
Week 0, 2, 4
Title
PROMIS Sleep Disturbance short form 4a, change in score
Description
The PROMIS Sleep Disturbance SF 4a is a 4-item self report measure of perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
Time Frame
Week 0, 2, 4
Title
PROMIS Sleep-Related Impairment short form 8a, change in score
Description
The PROMIS Sleep-Related Impairment SF 8a is an 8-item self reported measure of perceived alertness, sleepiness, and tiredness during usual waking hours. The 8 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 8 (good quality) to 40 (poor quality).
Time Frame
Weeks 0, 2, 4
Title
Epworth sleepiness scale, change in score
Description
The Epworth Sleepiness Scale is a widely used measure of daytime sleepiness. Scores range from 0 to 24; scores of greater than 10 indicate excessive daytime sleepiness.
Time Frame
Week 0, 2, 4
Other Pre-specified Outcome Measures:
Title
Vasomotor Symptom Survey
Description
Self-report 10-question survey of hot flash and night sweat number, duration, interference, bothersome rating, and control of interference. Score range 0 to 86 with higher score indicating greater negative impact of vasomotor symptoms.
Time Frame
Week 0, 1, 2, 3, 4
Title
Temperature-related quality of life and symptoms, change in score
Description
Self-report measure of temperature-related quality of life and symptoms. Scores range from 0 to 100 with higher scores indicating greater quality of life.
Time Frame
Week 0, 2, 4
Title
User acceptance
Description
Self-report 8-question survey at end of study.
Time Frame
Week 4
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have received a diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy or orchiectomy at least 1 month prior to enrollment.
May have received prior definitive radiation therapy or surgery (>60 days prior to study).
Have bothersome hot flashes (occurrence ≥ 28 times per week and at least moderately bothersome).
Presence of hot flashes for >30 days prior to study entry.
Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater).
Willing to downloading and use the Embr thermal device companion app on their phone
Willing to wear the Embr thermal device for 4 weeks, and charge and sync the device daily
In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English
Exclusion Criteria:
Planned treatment with chemotherapy and/or any medical intervention that will impact hot flashes, sleep, or other daily activities of daily life during the 4-week study.
History of a known sleep disorder, other than insomnia (eg, obstructive sleep apnea, restless leg syndrome), or medical or psychiatric condition that affects sleep, or undergoing treatment for insomnia.
History of cognitive impairment or dysfunction.
Seizure history, history of recurrent falls, or known brain metastases.
Uncontrolled intercurrent illness.
Individuals with a second malignancy other than non-melanoma skin cancers.
Individuals taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior.
Individuals taking prescription sleep medications.
Individuals who report consuming more than 7 alcoholic beverages/week and/or frequent alcohol consumption within 2 hours prior to bed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Morgans, MD, MPH
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Embr Labs (Remote study site)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
IPD Sharing Time Frame
Beginning 6 months after publication
IPD Sharing Access Criteria
Upon appropriate data request
Learn more about this trial
Embr Thermal Device for Hot Flash Management in Prostate Cancer
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