Wearable cooling device to ease hot flashes in men on ADT for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares immediate versus delayed use of the Embr Wave cooling device for 12 weeks in men with prostate cancer receiving ADT who have bothersome hot flashes. Participants are randomly assigned to start the device right away or after 6 weeks of usual care, with outcomes reported by patients. The study uses patient-reported measures to assess hot flash severity and quality of life. Enrollment is across Dana-Farber Cancer Institute sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Daniel Sentana Lledo, MD — Dana-Farber Cancer Institute
• Study coordinator: Daniel Sentana Lledo, MD
• Email: daniel_sentanalledo@dfci.harvard.edu
• Phone: 617-632-3466

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• Acupuncture vs Sham Acupuncture for Hot Flashes in Prostate Cancer on Hormone Therapy

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  Recruiting University of Kentucky · Lexington, Kentucky · NCT07594002

• Fezolinetant for hot flashes in men on hormone therapy for prostate cancer

  This study tests whether fezolinetant can reduce vasomotor symptoms in men receiving androgen deprivation therapy for prostate cancer.

  Recruiting Phase 2 Chinese University of Hong Kong · Shatin · NCT07568236

• Use of a smartwatch to track hot flashes in men receiving androgen deprivation therapy

  This project will try using a smartwatch to record hot flashes and other health signals in men with prostate cancer on androgen deprivation therapy and compare those records with daily survey reports.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT07535541

• Acupuncture to ease hot flashes in men on hormone therapy for prostate cancer

  This trial will test if weekly acupuncture plus lifestyle education can help reduce hot flashes and related symptoms in men receiving androgen deprivation therapy for prostate cancer.

  Recruiting Inova Health Care Services · Fairfax, Virginia · NCT07335224

• JDS-HF3.0 supplement to ease menopause symptoms in postmenopausal women

  This trial will see if taking two JDS-HF3.0 tablets each morning for 12 weeks can reduce hot flashes, night sweats, and joint discomfort in postmenopausal women aged 50–70.

  Recruiting Bonafide Health · Harrison, New York · NCT07238478

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.