Wrist Cooling for Hot Flashes Clinical Trial

• Sponsor: Boston University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05595213
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

This is a double blinded randomized clinical trial pilot study to investigate the impact of wrist cooling devices on symptom control of hot flashes in adult men with prostate cancer on medications that can suppress the production of the hormone testosterone known as androgen deprivation therapy (e.g. leuprolide (Lupron)) and women with breast cancer on medications to decrease the production of estrogen known as estrogen deprivation therapy (e.g. anastrozole) experiencing at least two hot flashes that are moderate or severe in intensity.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes	Device: Wrist cooling device; Other: Hot Flash Diary	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Double Blind Randomized Pilot Evaluation of the Response Profiles of Wrist Cooling Devices for Men With Prostate Cancer and Women With Breast Cancer on Hormone Deprivation Therapy Who Suffer From Moderate and or Severe Hot Flashes
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wrist Cooling Device A Participants randomized into this arm will be provided a wrist cooling device and instructed how to use it when they have a hot flash.	Device: Wrist cooling device; The wrist cooling 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. Participants will be randomly assigned to receive either the device that cools up to 5 minutes or up to 5 seconds when activated.; Other: Hot Flash Diary; 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.
Active Comparator: Wrist Cooling Device B Participants randomized into this arm will be provided a wrist cooling device and instructed how to use it when they have a hot flash.	Device: Wrist cooling device; The wrist cooling 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. Participants will be randomly assigned to receive either the device that cools up to 5 minutes or up to 5 seconds when activated.; Other: Hot Flash Diary; 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.

Outcome Measures

Primary Outcome Measures

1. Percent of hot flashes severity [6 weeks]

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

Secondary Outcome Measures

1. Number of times wrist cooling device activated [6 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. One of the following:

2. Diagnosis of prostate cancer and currently on androgen deprivation therapy with no plans to stop therapy within study period

3. Diagnosis of breast cancer and currently on estrogen deprivation therapy with no plans to stop therapy within study period

4. Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.

5. Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed

6. Severe: sensation of intense heat with sweating and causing disruption of current activity

7. English speaking

Exclusion Criteria:

1. Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.

2. Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.

3. Any lack of sensitivity to coolness on the wrists or hands

4. Any use of pharmaceuticals or devices to treat hot flashes.

5. Unable to understand and speak English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BU School of Medicine	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Michael F Holick, PhD MD, BU School of Medicine, Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT05595213
• Other Study ID Numbers: H-43277
• First Posted: Oct 26, 2022
• Last Update Posted: Feb 3, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Boston University: Prostate cancer; Breast cancer; Hormone deprivation therapy; Wrist cooling device
• Additional relevant MeSH terms: Hot Flashes

Study Results

No Results Posted as of Feb 3, 2023