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Wrist Cooling for Hot Flashes Clinical Trial

Primary Purpose

Hot Flashes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wrist cooling device with cooling plate

Wrist fan activating device without cooling plate

Hot Flash Diary

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Prostate cancer, Breast cancer, Hormone deprivation therapy, Wrist cooling device

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

One of the following:
1. Diagnosis of prostate cancer and currently on androgen deprivation therapy with no plans to stop therapy within study period
2. Diagnosis of breast cancer and currently on estrogen deprivation therapy with no plans to stop therapy within study period
Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
1. Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed
2. Severe: sensation of intense heat with sweating and causing disruption of current activity
English speaking

Exclusion Criteria:

Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.
Any lack of sensitivity to coolness on the wrists or hands
Any use of pharmaceuticals or devices to treat hot flashes.
Unable to understand and speak English

Sites / Locations

BU School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1 Wrist Cooling Devices

Group 2 Wrist Cooling Devices

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent of hot flashes severity

Participants will document the severity of hot flashes (mild, moderate, severe) in the study 'hot flash diary'.

Secondary Outcome Measures

Number of times wrist cooling device activated

Activation of the device will be documented by the device and by participants on the 'hot flash diary'.

Full Information

NCT ID

NCT05595213

First Posted

October 21, 2022

Last Updated

August 30, 2023

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT05595213

Brief Title

Wrist Cooling for Hot Flashes Clinical Trial

Official Title

Pilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 5, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices on symptom control of hot flashes in adult men and adult women experiencing hot flashes. The participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a diary. The participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. They will wear the first assigned device for weeks 3 and 4. They will record in their diary the severity of their hot flashes while using the device. For weeks 5 and 6 they will be ask to use a second device and record in their diary the severity of their hot flashes with the use of the device. The devices will be attached to the wrist like a watch. When activated, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active.

Detailed Description

The randomized group will determine the order that a participant uses each device. Group 1 participants will use the wrist cooling device first for two weeks and then the fan activating device for two weeks. Group 2 participants will use the fan activating device first for two weeks followed by the wrist cooling device for two weeks. This will be a 6 week study requiring the participants to see a study team member at the beginning of the study. The participants will receive three phone calls during the study to remind them of when to use each device. They will be instructed after the 6 weeks for them to have an in person return visit and give the diaries and the devices to the study personnel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes

Keywords

Prostate cancer, Breast cancer, Hormone deprivation therapy, Wrist cooling device

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 Wrist Cooling Devices

Arm Type

Experimental

Arm Description

Arm Title

Group 2 Wrist Cooling Devices

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Wrist cooling device with cooling plate

Intervention Description

This device is worn like a watch and pressing the button activates the cooling function to begin to col the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.

Intervention Type

Device

Intervention Name(s)

Wrist fan activating device without cooling plate

Intervention Description

This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.

Intervention Type

Other

Intervention Name(s)

Hot Flash Diary

Intervention Description

Participants will be instructed to daily document each hot flash experience and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.

Primary Outcome Measure Information:

Title

Percent of hot flashes severity

Description

Participants will document the severity of hot flashes (mild, moderate, severe) in the study 'hot flash diary'.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Number of times wrist cooling device activated

Description

Activation of the device will be documented by the device and by participants on the 'hot flash diary'.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity. Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed Severe: sensation of intense heat with sweating and causing disruption of current activity English speaking Exclusion Criteria: Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons. Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist. Any lack of sensitivity to coolness on the wrists or hands Any use of pharmaceuticals or devices to treat hot flashes. Unable to understand and speak English

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael F Holick, PhD MD

Phone

(617) 358-6139

mfholick@bu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nazli Ucar, MS

Phone

(617) 358-6139

nucar@bu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael F Holick, PhD MD

Organizational Affiliation

BU School of Medicine, Endocrinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

BU School of Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael F Hollick, PhD MD

Phone

617-358-6139

mfholick@bu.edu

12. IPD Sharing Statement

Plan to Share IPD

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Wrist Cooling for Hot Flashes Clinical Trial

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