Embr Thermal Device for Hot Flash Management in Prostate Cancer

NCT04892914 | Completed

• 1 other identifier: EMBR-PC-001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Hot Flashes

Keywords

androgen deprivation therapy; orchiectomy; prostate carcinoma; night sweats; hormone therapy

Outcome Measures

Primary Outcomes (2)

• Embr thermal device usage, average number of minutes per day per participant

  Number of minutes logged with the Embr device.

  Weeks 0 to 4

• Embr thermal device usage, average number of sessions per day per participant

  Number of sessions logged with the Embr device.

  Weeks 0 to 4

Secondary Outcomes (4)

• Hot Flash Related Daily Interference Scale (HFRDIS), change in score

  Week 0, 2, 4

• PROMIS Sleep Disturbance short form 4a, change in score

  Week 0, 2, 4

• PROMIS Sleep-Related Impairment short form 8a, change in score

  Weeks 0, 2, 4

• Epworth sleepiness scale, change in score

  Week 0, 2, 4

Other Outcomes (3)

• Vasomotor Symptom Survey

  Week 0, 1, 2, 3, 4

• Temperature-related quality of life and symptoms, change in score

  Week 0, 2, 4

• User acceptance

  Week 4

Study Arms (1)

Embr thermal device

EXPERIMENTAL

Use of the Embr thermal device

Device: Embr thermal device

Interventions

Embr thermal device DEVICE

Participants use the Embr thermal device for 4 weeks

Embr thermal device

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Embr Labs, Inc.: lead

Study Sites (1)

Embr Labs (Remote study site)

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia Morgans, MD, MPH

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Embr thermal device

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: May 28, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication
• Access Criteria: Upon appropriate data request

Locations

US (1)