Clinical trial NCT04892914: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Hot Flashes
Keywords: androgen deprivation therapy
orchiectomy
prostate carcinoma
night sweats
hormone therapy
Lead sponsor: Embr Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Embr thermal device
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Embr thermal device usage, average number of minutes per day per participant
timeFrame: Weeks 0 to 4
measure: Embr thermal device usage, average number of sessions per day per participant
timeFrame: Weeks 0 to 4
Secondary outcomes:
measure: Hot Flash Related Daily Interference Scale (HFRDIS), change in score
timeFrame: Week 0, 2, 4
measure: PROMIS Sleep Disturbance short form 4a, change in score
timeFrame: Week 0, 2, 4
measure: PROMIS Sleep-Related Impairment short form 8a, change in score
timeFrame: Weeks 0, 2, 4
measure: Epworth sleepiness scale, change in score
timeFrame: Week 0, 2, 4
Other outcomes:
measure: Vasomotor Symptom Survey
timeFrame: Week 0, 1, 2, 3, 4
measure: Temperature-related quality of life and symptoms, change in score
timeFrame: Week 0, 2, 4
measure: User acceptance
timeFrame: Week 4
Locations:
city: Boston
country: United States
facility: Embr Labs (Remote study site)
state: Massachusetts
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Alicia Morgans, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: