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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hot flushes
Secondary outcome measures
Wrist

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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Who is running the clinical trial?

Boston UniversityLead Sponsor
461 Previous Clinical Trials
9,951,665 Total Patients Enrolled
Michael F Holick, PhD MDPrincipal InvestigatorBU School of Medicine, Endocrinology

Media Library

Group 1 Wrist Cooling Devices Clinical Trial Eligibility Overview. Trial Name: NCT05595213 — N/A
Hot Flashes Research Study Groups: Group 1 Wrist Cooling Devices, Group 2 Wrist Cooling Devices
Hot Flashes Clinical Trial 2023: Group 1 Wrist Cooling Devices Highlights & Side Effects. Trial Name: NCT05595213 — N/A
Group 1 Wrist Cooling Devices 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595213 — N/A
~13 spots leftby Jul 2025
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