Clinical trial NCT05595213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Keywords: Breast cancer
Prostate cancer
Hormone deprivation therapy
Wrist cooling device
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

The investigators will recruit participants and conduct the study at the Boston University School of Medicine (BUSM), locally, and virtually.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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

Primary outcomes:
measure: Percent of hot flashes severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of times wrist cooling device activated
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU School of Medicine
state: Massachusetts
Study officials:
affiliation: BU School of Medicine, Endocrinology
name: Michael F Holick, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: