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

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07729150
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Embr Wave — DEVICE
    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.

Study Details

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

Key Dates

First listed
Jul 27, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Embr Wave Device Use
    Participants receive the Embr Wave device at the start of the study and use it for 12 weeks.
  • Active Comparator: Delayed Embr Wave Device Use
    Participants receive usual care for the first 6 weeks, then receive the Embr Wave device for the next 6 weeks.

Primary Outcome Measure

Hot Flash Related Daily Interference Scale (HFRDIS) Score [ Time Frame: Assessed 6 weeks after randomization ]

Central Contacts

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