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Trial NCT07729150

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

Phase
Not given
Sponsor
Dana-Farber Cancer Institute
Conditions
Prostate Cancer; Hot Flashes; Vasomotor Symptoms
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 ≤ 2Performance status * 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.Pregnancy * 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.

Restrictions found (2)

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute · Boston, Suffolk County