Embr Thermal Device for Hot Flash Management in Prostate Cancer

Completed · Not applicable

Conditions studied: Prostate Cancer, Hot Flashes

In brief

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.

Key facts

Study ID

NCT04892914

Run by

Embr Labs, Inc.

People needed

57

Starts

2021-05-28

Expected to finish

2021-12-05

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Embr Labs (Remote study site) — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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