NCT07729150Recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT07729150
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 1 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Pregnant and nursing women are excluded as prostate cancer is a disease of men.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.