COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary
研究概览
简要总结
This research study will investigate whether using a non-drug option, like a cooling mat, made of temperature-regulating materials, can help relieve the discomfort of hot flushes and/or night sweats for people receiving hormone treatment following a cancer diagnosis.
Cooling mats are made from specialised material designed to keep body temperature in a comfortable range by reducing heat. Previous research has shown these materials can be helpful for managing hot flushes during menopause, and the investigators are investigating if the same benefits apply to cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at time of consent
- •Histologically confirmed diagnosis of breast cancer or prostate cancer
- •Currently receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression therapy, androgen deprivation therapy)
- •Self-reported vasomotor symptoms (e.g., hot flushes and/or night sweats) occurring at least once daily during the 2 weeks prior to screening
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Prior use of cooling mat devices specifically for management of vasomotor symptoms within the past 3 months
- •Known hypersensitivity or allergy to polyvinyl chloride (PVC) or any component of the cooling mat device
- •Cognitive impairment, psychiatric condition, or other medical condition that, in the opinion of the investigator, would interfere with adherence to study procedures
- •Concurrent participation in another interventional clinical trial for management of vasomotor symptoms
研究组 & 干预措施
Cooling Mat
This is a prospective single arm pilot study to assess the feasibility and effectiveness of cooling mats in reducing the frequency and severity of vasomotor symptoms.
干预措施: Cooling Gel Mats (Other)
结局指标
主要结局
Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary
时间窗: 8 weeks
Reduction in Severity and Frequency of Vasomotor Symptoms Description: Participants will record daily hot flash frequency and severity (1=mild, 2=moderate, 3=severe). Weekly Hot Flash Score is calculated as frequency × severity. Higher scores indicate worse symptom burden. The outcome is the mean change in weekly Hot Flash Score from baseline to Week 8.
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0(8weeks)
- Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks(8 weeks)
- Sleep quality(8 Weeks)
- QoL(8 weeks)
研究者
Breege Farrelly
Advanced Nurse Practitioner
Sligo General Hospital