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Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes
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
Who can join
Ages 18 and older · Men
Full eligibility criteria
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.
About the study
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
What is being tested
- Embr Wave (device)
Sponsor: Dana-Farber Cancer Institute · Participants: 66 · Started: Oct 1, 2026
Contact the study team
- Daniel Sentana Lledo, MD · Phone: 617-632-3466
Official record on ClinicalTrials.gov — NCT07729150
Locations in the U.S.
| Massachusetts | Dana-Farber Cancer Institute, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.