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Набор скоро начнётся NCT07729150

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

Без фазы С лечением Prostate Cancer Hot Flashes Vasomotor Symptoms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Embr Wave.
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Hot Flashes, Vasomotor Symptoms. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07729150 · 26-227

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗