Recruiting

Embr Wave

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07729150

Conditions

Prostate Cancer

Hot Flashes

Vasomotor Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Embr Wave

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Hot Flashes

Vasomotor Symptoms

Study ID

NCT07729150

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Embr Wave Device Use

Participants receive the Embr Wave device at the start of the study and use it for 12 weeks.

active comparator: Delayed Embr Wave Device Use

Participants receive usual care for the first 6 weeks, then receive the Embr Wave device for the next 6 weeks.

Interventions

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.

Primary outcome measure

  • Hot Flash Related Daily Interference Scale (HFRDIS) Score [ Time Frame: Assessed 6 weeks after randomization ]

Central Contacts and Locations

Central contacts

Daniel Sentana Lledo, MD

617-632-3466daniel_sentanalledo@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Daniel Sentana, MD

daniel_sentanalledo@dfci.harvard.edu

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Prostate Cancer
  • Hot Flashes
  • Vasomotor Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.