Embr Thermal Device for Hot Flash Management in Prostate Cancer

Embr Labs

Status

Completed

Conditions

Hot Flashes

Prostate Cancer

Treatments

Device: Embr thermal device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04892914

EMBR-PC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.