Embr Thermal Device for Hot Flash Management in Prostate Cancer

NCT ID: NCT04892914

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2021-12-05

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.

Conditions

Prostate Cancer; Hot Flashes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embr thermal device

Use of the Embr thermal device

Group Type: EXPERIMENTAL

Embr thermal device

Intervention Type: DEVICE

Participants use the Embr thermal device for 4 weeks

Interventions

Embr thermal device

Participants use the Embr thermal device for 4 weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Embr Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alicia Morgans, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Embr Labs (Remote study site)

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

EMBR-PC-001

Identifier Type: -

Identifier Source: org_study_id