Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- change in number of daily hot flashes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Has another existing medical condition that would prevent study compliance.
研究组 & 干预措施
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.)
干预措施: Cooling Vest (Device)
结局指标
主要结局
change in number of daily hot flashes
时间窗: 4 weeks
diary will be used to record the number of daily hot flashes
change in the intensity of daily hot flashes
时间窗: 4 weeks
diary will be used to record the severity of daily hot flashes
次要结局
未报告次要终点