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Not yet recruiting NCT07729150

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

No phase Interventional Prostate Cancer Hot Flashes Vasomotor Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embr Wave.
Who it may be relevant to
Registry conditions: Prostate Cancer, Hot Flashes, Vasomotor Symptoms. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Detailed description

This is a randomized, supportive care trial in which men with prostate cancer on ADT and experiencing bothersome hot flashes will be assigned to either immediate use of the Embr Wave device for 12 weeks or delayed use (usual care for 6 weeks, then device for 6 weeks). The Embr Wave is a commercially available wearable device that provides a cooling sensation and is being tested for its ability to reduce hot flash severity and improve quality of life. Participants will be enrolled across the DF/HCC consortium and collaborative sites.

Interventions

  • Device Embr Wave
    A wearable thermal device that provides a cooling sensation on the wrist. The device is commercially available but not specifically approved for hot flashes in men with prostate cancer.

Primary outcome measures

  • Hot Flash Related Daily Interference Scale (HFRDIS) Score [Time frame: Assessed 6 weeks after randomization]
Secondary outcome measures (9)
  • HFRDIS Score [week 12] [Time frame: Assessed at 12 weeks after randomization]
  • Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score [Time frame: Assessed at 6 weeks and 12 weeks after randomization]
  • PROMIS Sleep-Related Impairment Score [Time frame: Assessed at 6 weeks and 12 weeks after randomization]
  • HFRDIS Score Change from Baseline to Week 6 [Time frame: Assessed at baseline and 6 weeks after randomization]
  • HFRDIS Score Change from Week 6 to Week 12 [Time frame: Assessed at 6 weeks and 12 weeks after randomization]
  • PROMIS Sleep Disturbance Score Change from Baseline to Week 6 [Time frame: Assessed at baseline and 6 weeks after randomization]
  • PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12 [Time frame: Assessed at 6 and 12 weeks after randomization]
  • PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6 [Time frame: Assessed at baseline and 6 weeks after randomization]
  • PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12 [Time frame: Assessed at 6 and 12 weeks after randomization]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07729150 · 26-227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗