Prostate CancerNCT04892914
Embr Thermal Device for Hot Flash Management in Prostate Cancer
A study testing Embr thermal device in people with Prostate Cancer and Hot Flashes, run by Embr Labs, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Hot Flashes
- What is being tested?
- Embr thermal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Embr Labs (Remote study site)
Boston, Massachusetts, 02129
About this study
Official title: Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer, Hot Flashes
- Being tested
- Embr thermal device
- Keywords
- androgen deprivation therapy, orchiectomy, prostate carcinoma, night sweats, hormone therapy
- Medical subject headings
- Prostatic Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embr thermal deviceDevice
Participants use the Embr thermal device for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Embr thermal device | Experimental | Use of the Embr thermal device Receives: Device: Embr thermal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embr thermal device usage, average number of minutes per day per participant
Number of minutes logged with the Embr device.
Measured: Weeks 0 to 4
Embr thermal device usage, average number of sessions per day per participant
Number of sessions logged with the Embr device.
Measured: Weeks 0 to 4
Secondary outcomes (4)
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.
Measured: Week 0, 2, 4
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).
Measured: Week 0, 2, 4
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).
Measured: Weeks 0, 2, 4
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.
Measured: Week 0, 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start28 May 2021
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Embr thermal device
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embr Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia Morgans, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892914
- Sponsor's protocol ID
- EMBR-PC-001
- Status last verified
- Apr 2022
- First submitted
- 11 May 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04892914
- Acronym / sponsor ID
- EMBR-PC-001
- Conditions
- Prostate Cancer, Hot Flashes
- Keywords
- androgen deprivation therapy, orchiectomy, prostate carcinoma, night sweats, hormone therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Embr Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Embr thermal device
| Arm | Type | Receives |
|---|---|---|
| Embr thermal device | Experimental | Device: Embr thermal deviceUse of the Embr thermal device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Embr thermal deviceParticipants use the Embr thermal device for 4 weeks | Device | Embr thermal device |
Primary outcome
Embr thermal device usage, average number of minutes per day per participant
Time frame: Weeks 0 to 4
Number of minutes logged with the Embr device.
Embr thermal device usage, average number of sessions per day per participant
Time frame: Weeks 0 to 4
Number of sessions logged with the Embr device.
4 secondary outcomes
Hot Flash Related Daily Interference Scale (HFRDIS), change in score
Time frame: Week 0, 2, 4
PROMIS Sleep Disturbance short form 4a, change in score
Time frame: Week 0, 2, 4
PROMIS Sleep-Related Impairment short form 8a, change in score
Time frame: Weeks 0, 2, 4
Epworth sleepiness scale, change in score
Time frame: Week 0, 2, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
Alicia Morgans, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embr thermal device in people with Prostate Cancer and Hot Flashes, run by Embr Labs, Inc. 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 9 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: finished, as of the sponsor's last update on 5 Apr 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Embr thermal device usage, average number of minutes per day per participant (time frame: Weeks 0 to 4). The study lists 2 primary outcomes in all. 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 5 Apr 2022.