RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 6 weeks
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Embr Wave wearable device reduces hot flashes in men with prostate cancer who take hormone-lowering treatment called ADT. Participants are assigned by chance to use the device right away for 12 weeks or to start after 6 weeks. They will report how hot flashes affect them.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer confirmed by a doctor's exam or tissue testing.
  • Have taken standard ADT for at least 4 weeks and stay on it for the 12-week study. Some other cancer treatments may be taken with ADT.
  • Have at least 28 hot flashes per week that are at least moderately bothersome, for at least 30 days before joining.
  • Be age 18 or older.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours (ECOG score 0–2).
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Be pregnant or breastfeeding.
  • Have another illness, including another cancer, that may limit your life to less than 6 months.
  • Receive cancer drugs that work throughout the body, other than ADT or allowed treatments: approved androgen receptor pathway inhibitors (drugs that block male hormone signals), radioligand therapy (targeted radiation drugs), or immunotherapy (treatment that uses the immune system). Trials using standard treatments in these allowed groups are permitted.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA