Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Vasomotor Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embr Wave | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate Embr Wave Device Use
- description
- Participants receive the Embr Wave device at the start of the study and use it for 12 weeks.
- interventionNames
- Device: Embr Wave
- type
- ACTIVE_COMPARATOR
- label
- Delayed Embr Wave Device Use
- description
- Participants receive usual care for the first 6 weeks, then receive the Embr Wave device for the next 6 weeks.
- interventionNames
- Device: Embr Wave
Primary outcomes (1)
- measure
- Hot Flash Related Daily Interference Scale (HFRDIS) Score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available