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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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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
454 Previous Clinical Trials
9,941,540 Total Patients Enrolled
Michael F Holick, PhD MDPrincipal InvestigatorBU School of Medicine, Endocrinology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience discomfort when wearing devices like watches on my wrist.I experience increased sensitivity to cold due to an autoimmune or vascular condition.I use medication or devices to manage hot flashes.I cannot feel cold on my wrists or hands.I experience hot flashes that are intense but can continue my activities with brief cooling.I experience 2 or more moderate to severe hot flashes daily.I experience severe hot flashes that interrupt my activities.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 Wrist Cooling Devices
- Group 2: Group 2 Wrist Cooling Devices
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for new subjects in this clinical trial?
"According to the latest information on clinicaltrials.gov, this particular trial is not looking for new patients at the moment. The trial was first announced on December 1st, 2022 and was last updated on October 25th, 2022. That being said, there are 27 other trials that are currently looking for participants."
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