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Wrist Cooling Devices for Hot Flashes

N/A

Recruiting

Led By Michael F Holick, PhD MD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates how cooling devices can help reduce hot flashes in people with prostate or breast cancer on hormone-blocking meds.

Who is the study for?

This trial is for adult men and women who have breast or prostate cancer, are undergoing hormone deprivation therapy, and experience at least two moderate to severe hot flashes daily. Participants must speak English and plan to continue their current therapy during the study. Those with temperature sensitivity disorders, lack of coolness sensation in wrists/hands, use of other hot flash treatments, or discomfort wearing wrist devices cannot join.

What is being tested?

The study tests two wrist-worn cooling devices: one with a cooling plate and fan, the other with just a fan. Over six weeks, participants will wear each device for two weeks while recording hot flash severity in a diary. The goal is to see if there's a difference in relief between the two devices.

What are the potential side effects?

Since this trial involves non-invasive cooling devices similar to wearing a watch that activates for short periods, side effects may be minimal but could include skin irritation at the site of application or discomfort from wearing the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hot flushes

Secondary study objectives

Wrist

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 Wrist Cooling DevicesExperimental Treatment3 Interventions

Participants randomized into Group 2 will be provided two wrist cooling devices that are worn like watches. Group 2 participants will be instructed to first use the cooling watch device that activates the fan without the cooling plate for 2 weeks and then stop using it and switch to using the skin cooling watch device with the cooling plate.

Group II: Group 1 Wrist Cooling DevicesExperimental Treatment3 Interventions

Participants randomized into Group 1 will be provided two wrist cooling devices that are worn like watches. Group 1 participants will be instructed to first use the skin cooling watch device with a cooling plate for 2 weeks and then stop using it and switch to using the watch device that activates the fan without the cooling plate for 2 weeks.

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