Cooling Vest in Men With Hot Flashes
- Conditions
- Hot Flashes
- Interventions
- Device: Cooling Vest
- Registration Number
- NCT03000322
- Lead Sponsor
- Englewood Hospital and Medical Center
- Brief Summary
This study is intended to determine the efficacy of the Cooling Vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.
- Detailed Description
The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.
This study attempts to collect data on the effects of the Cooling Vest in men with hot flashes and night sweats due to the side effects of chemotherapy. Participants will use the vest for 4 weeks and questionnaires will be used to determine effect.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- Males, who are at least 18 years old.
- Self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats.
- Has another existing medical condition that would prevent study compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cooling Vest Cooling Vest During the four-week Treatment Period, participants should use the Cooling Vest two times per day (once in the morning for one hour and once in the evening for one hour.)
- Primary Outcome Measures
Name Time Method change in number of daily hot flashes 4 weeks diary will be used to record the number of daily hot flashes
change in the intensity of daily hot flashes 4 weeks diary will be used to record the severity of daily hot flashes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Urology Center Research Institute
🇺🇸Englewood, New Jersey, United States