Hot Flashes
Conditions
Keywords
Breast cancer, Prostate cancer, Hormone deprivation therapy, Wrist cooling device
Brief summary
This pilot study aims to determine the impact of an experimental active cooling wrist device compared to a placebo device \[the devices look identical\] 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 study diary. Each participant will wear each of the two devices \[active cooling and placebo\] during the trial but the order of which device they wear first will be determined by their random assignment into a group. The devices are identical in appearance and neither the participant nor the investigators w ill know which device the participants are wearing. Participants 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 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, the experimental active cooling device will turn on a cooling fan with the cooling plate being active for up to 5 minutes. In contrast, the placebo device will only turn on a cooling fan for up to 5 minutes without the cooling plate being active.
Interventions
DEVICEActive cooling device with cooling plate
This device is worn like a watch and pressing the button activates the cooling function to begin to cool the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.
DEVICEPlacebo device without cooling plate
This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.
OTHERHot Flash Diary
Participants will be instructed to document each hot flash experience daily and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.
Sponsors
Boston University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this study all participants will wear both the active wrist cooling device and the placebo device that look identical. However, the order that they wear the devices \[which one they wear first or second\] will be determined randomly.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Hot Flashes | 6 weeks | Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'. |
Countries
United States
Participant flow
Pre-assignment details
Participants recorded baseline frequency and severity for 2 weeks and then were randomly assigned the order of which of the two devices they would wear first \[active cooling or placebo\] which they did for 2 weeks. After 2 weeks of follow up they wore the other device for 2 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Wrist Active Cooling and Placebo Device All participants wore both the active cooling and placebo devices for 2 weeks each. The order of which device was worn first was randomly determined. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Wrist Active Cooling and Placebo Device | — |
|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 15.7 | — |
| Baseline number and severity of hot flashes Mild | 785 number of hot flashes | — |
| Baseline number and severity of hot flashes Moderate | 1317 number of hot flashes | — |
| Baseline number and severity of hot flashes Severe | 1195 number of hot flashes | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 27 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Number and Severity of Hot Flashes
Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'.
Time frame: 6 weeks
Population: Each participant wore an active cooling wrist device and a placebo wrist device during the study so there are data on both for each of the 27 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Cooling Device | Number and Severity of Hot Flashes | Severe | 633 number of hot flashes |
| Active Cooling Device | Number and Severity of Hot Flashes | Mild | 1148 number of hot flashes |
| Active Cooling Device | Number and Severity of Hot Flashes | Moderate | 924 number of hot flashes |
| Placebo Device | Number and Severity of Hot Flashes | Moderate | 1213 number of hot flashes |
| Placebo Device | Number and Severity of Hot Flashes | Severe | 1117 number of hot flashes |
| Placebo Device | Number and Severity of Hot Flashes | Mild | 692 number of hot flashes |