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NCT Number: NCT07729150

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hot Flashes Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Vasomotor Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

This is a randomized, supportive care trial in which men with prostate cancer on ADT and experiencing bothersome hot flashes will be assigned to either immediate use of the Embr Wave device for 12 weeks or delayed use (usual care for 6 weeks, then device for 6 weeks). The Embr Wave is a commercially available wearable device that provides a cooling sensation and is being tested for its ability to reduce hot flash severity and improve quality of life. Participants will be enrolled across the DF/HCC consortium and collaborative sites.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Hot Flash Related Daily Interference Scale (HFRDIS) Score

    Time frame: Assessed 6 weeks after randomization

    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.

Secondary outcomes

  1. HFRDIS Score [week 12]

    Time frame: Assessed at 12 weeks after randomization

    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.

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

    Time frame: Assessed at 6 weeks and 12 weeks after randomization

    PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).

  3. PROMIS Sleep-Related Impairment Score

    Time frame: Assessed at 6 weeks and 12 weeks after randomization

    PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).

  4. HFRDIS Score Change from Baseline to Week 6

    Time frame: Assessed at baseline and 6 weeks after randomization

    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.

  5. HFRDIS Score Change from Week 6 to Week 12

    Time frame: Assessed at 6 weeks and 12 weeks after randomization

    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.

  6. PROMIS Sleep Disturbance Score Change from Baseline to Week 6

    Time frame: Assessed at baseline and 6 weeks after randomization

    PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).

  7. PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12

    Time frame: Assessed at 6 and 12 weeks after randomization

    PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).

  8. PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6

    Time frame: Assessed at baseline and 6 weeks after randomization

    PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).

  9. PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12

    Time frame: Assessed at 6 and 12 weeks after randomization

    PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Sentana Lledo, MD

CONTACT

[email protected]

617-632-3466

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Reduce Hot flashEs AssociaTed With ADT (Reduce HEAT) - a Prospective Randomized Clinical Trial of a Wearable Thermal Device for Patients With Prostate Cancer on ADT With Bothersome Vasomotor Symptoms

Acronym: Reduce HEAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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