Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Embr Wave
DeviceA 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Immediate Embr Wave Device UseExperimental treatment 1 intervention
Group B: Delayed Embr Wave Device UseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hot Flash Related Daily Interference Scale (HFRDIS) Score
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame
Assessed 6 weeks after randomizationSecondary outcomes
1
HFRDIS Score [week 12]
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame
Assessed at 12 weeks after randomization2
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame
Assessed at 6 weeks and 12 weeks after randomization3
PROMIS Sleep-Related Impairment Score
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame
Assessed at 6 weeks and 12 weeks after randomization4
HFRDIS Score Change from Baseline to Week 6
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame
Assessed at baseline and 6 weeks after randomizationSponsors and contacts
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Source ClinicalTrials.gov