Prostate Cancer Clinical Trial
Wrist Cooling for Hot Flashes Clinical Trial
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.
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.
One of the following:
Diagnosis of prostate cancer and currently on androgen deprivation therapy with no plans to stop therapy within study period
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.
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
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
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There is 1 Location for this study
Boston Massachusetts, 02118, United States More Info
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