2023-507847-13-00招募中3 期
A randomized intrapatient cross-over study to assess the efficacy of oxybutynin versus venlafaxine in REDucing hot FLASHes in women using endocrine therapy after breast cancer: the RED FLASH study.
Reinier de Graaf Groep1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年4月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Number and severity of hot flashes during 6-week therapy measured by the Hot Flash Diary on a daily basis.
研究概览
简要总结
To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
研究设计
- 分配方式
- Randomized
- 主要目的
- The RED FLASH study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Pre-, peri- or postmenopausal women of 18 years or above; - Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study; - Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnant; - Breast feeding; - Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period; - Palliative setting; - Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year; - Creatinine clearance < 30 ml/min; - Liver cirrhosis; - Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry; - Use of oxybutynin before study entry; - Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.
结局指标
主要结局
Number and severity of hot flashes during 6-week therapy measured by the Hot Flash Diary on a daily basis.
Number and severity of hot flashes during 6-week therapy measured by the Hot Flash Diary on a daily basis.
次要结局
- Adverse events, sleep quality, quality of life, health status, anxiety and depression, cognitive function, sexual function, personal preference, adherence
研究者
Maaike de Leeuw
Scientific
Reinier de Graaf Groep
研究点 (1)
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