Status:
COMPLETED
Embr Thermal Device for Hot Flash Management in Prostate Cancer
Lead Sponsor:
Embr Labs, Inc.
Conditions:
Prostate Cancer
Hot Flashes
Eligibility:
MALE
18+ years
Phase:
NA
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04892914
Start Date
May 28 2021
End Date
December 5 2021
Last Update
April 5 2022
Active Locations (1)
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1
Embr Labs (Remote study site)
Boston, Massachusetts, United States, 02129