Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes | NCT07729150

NCT07729150

Overview

NCT ID: NCT07729150
Lead Sponsor: Dana-Farber Cancer InstituteOTHER
Official 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
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

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
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.

Central Contacts: Daniel Sentana Lledo, MDContact
daniel_sentanalledo@dfci.harvard.edu