Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes

NCT07729150 | Recruiting DMC FDA Device

• 1 other identifier: 26-227
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, non-pharmacologic interventional trial evaluating the effectiveness of the Embr Wave wearable thermal device in reducing hot flash burden in men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will be randomized 1:1 to immediate (12 weeks) versus delayed (after 6 weeks) use of the Embr Wave device. The study aims to determine whether the device reduces vasomotor symptoms using a number of patient-reported outcomes

Conditions

Prostate Cancer; Hot Flashes; Vasomotor Symptoms

Keywords

Prostate Cancer; Hot Flashes; Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

• Hot Flash Related Daily Interference Scale (HFRDIS) Score

  HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.

  Assessed 6 weeks after randomization

Secondary Outcomes (9)

• HFRDIS Score [week 12]

  Assessed at 12 weeks after randomization

• Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

  Assessed at 6 weeks and 12 weeks after randomization

• PROMIS Sleep-Related Impairment Score

  Assessed at 6 weeks and 12 weeks after randomization

• HFRDIS Score Change from Baseline to Week 6

  Assessed at baseline and 6 weeks after randomization

• HFRDIS Score Change from Week 6 to Week 12

  Assessed at 6 weeks and 12 weeks after randomization

Study Arms (2)

Immediate Embr Wave Device Use

EXPERIMENTAL

Participants receive the Embr Wave device at the start of the study and use it for 12 weeks.

Device: Embr Wave

Delayed Embr Wave Device Use

ACTIVE COMPARATOR

Participants receive usual care for the first 6 weeks, then receive the Embr Wave device for the next 6 weeks.

Device: Embr Wave

Interventions

Embr Wave DEVICE

A wearable thermal device that provides a cooling sensation on the wrist. The device is commercially available but not specifically approved for hot flashes in men with prostate cancer.

Delayed Embr Wave Device Use; Immediate Embr Wave Device Use

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women by birth are not affected by prostate cancer and therefore are not eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clinical or pathologic confirmed diagnosis of prostate cancer
• Patients must be undergoing treatment with standard androgen deprivation therapy (i.e., GnRH agonist or antagonist) for ≥ 4 weeks. Patients must remain on ADT for the duration of the study (12 weeks); they may receive treatment with an androgen receptor pathway inhibitor (ARPI), radioligand therapy, or immunotherapy combined with ADT.
• Patients must report bothersome hot flash symptoms (defined as ≥ 28 hot flashes per week, perceived to be at least moderately bothersome to the patient), during a period of at least 30 days prior to entering the study.
• Age ≥18 years.
• ECOG performance status ≤ 2
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Pregnant and nursing women are excluded as prostate cancer is a disease of men.
• Participants with a concurrent diagnosis, including separate malignancy, that may limit life expectancy \< 6 months.
• Systemic antineoplastic therapy besides approved ARPI, radioligand therapy, and immunotherapy - enrollment in a clinical trial that is using SOC therapeutic options in these categories is allowed.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

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

• Daniel Sentana Lledo, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Sentana Lledo, MD

CONTACT

617-632-3466; daniel_sentanalledo@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Immediate vs. delayed device use

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

Locations

US (1)