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Embr Wave for Hot Flashes

(ReduceHEAT Trial)

DS
Overseen ByDaniel Sentana Lledo, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

DS

Daniel Sentana Lledo, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older with prostate cancer who are on hormone therapy (ADT) and have bothersome hot flashes (at least 28 per week). Participants must be able to consent, in good enough health to participate, and willing to stay on their current treatment during the study.

Inclusion Criteria

I am able and willing to sign a consent form.
I am 18 years old or older.
I have been diagnosed with prostate cancer.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Embr Wave

Trial Overview

The study tests whether a wearable device called Embr Wave can help reduce hot flashes caused by hormone therapy in prostate cancer patients. Participants are randomly assigned to start using the device right away or after six weeks, over a total of twelve weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Immediate Embr Wave Device UseExperimental Treatment1 Intervention
Group II: Delayed Embr Wave Device UseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

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