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
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)
- Performance statusOutrightinclusion
ECOG ≤ 2
Show in the text - PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County