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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Hot Flash Related Daily Interference Scale (HFRDIS) Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hot Flash Related Daily Interference Scale (HFRDIS) Score
时间窗: Assessed 6 weeks after randomization
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.
次要结局
- HFRDIS Score [week 12](Assessed at 12 weeks after randomization)
- Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score(Assessed at 6 weeks and 12 weeks after randomization)
- PROMIS Sleep-Related Impairment Score(Assessed at 6 weeks and 12 weeks after randomization)
- HFRDIS Score Change from Baseline to Week 6(Assessed at baseline and 6 weeks after randomization)
- HFRDIS Score Change from Week 6 to Week 12(Assessed at 6 weeks and 12 weeks after randomization)
- PROMIS Sleep Disturbance Score Change from Baseline to Week 6(Assessed at baseline and 6 weeks after randomization)
- PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12(Assessed at 6 and 12 weeks after randomization)
- PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6(Assessed at baseline and 6 weeks after randomization)
- PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12(Assessed at 6 and 12 weeks after randomization)
研究者
Daniel Sentana Lledo
Principal Investigator
Dana-Farber Cancer Institute