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.
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
研究概览
简要总结
The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
The objectives it aims to answer are:
- To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer
- To assess side effects of oxybutynin versus venlafaxine.
- To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes.
- To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.
Participants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total.
Researchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
研究组 & 干预措施
Venlafaxine
In this open-label randomized controlled intrapatient cross-over study patients are randomly assigned to one of the two treatment groups.
After a one week baseline period, group 1 starts with venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks followed by a two-week wash-out period (no medication), hereafter the group starts with oxybutynin 5 mg twice per day for 6 weeks total.
干预措施: Oxybutynin (Drug)
Venlafaxine
In this open-label randomized controlled intrapatient cross-over study patients are randomly assigned to one of the two treatment groups.
After a one week baseline period, group 1 starts with venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks followed by a two-week wash-out period (no medication), hereafter the group starts with oxybutynin 5 mg twice per day for 6 weeks total.
干预措施: Venlafaxine (Drug)
Oxybutynin
After a one week baseline period, group 2 starts with oxybutynin 5 mg twice per day for 6 weeks total followed by a two-week wash-out period (no medication), hereafter the group starts with venlafaxine 37.5 mg once daily for 7 days followed by 75mg once daily for 5 weeks.
干预措施: Oxybutynin (Drug)
Oxybutynin
After a one week baseline period, group 2 starts with oxybutynin 5 mg twice per day for 6 weeks total followed by a two-week wash-out period (no medication), hereafter the group starts with venlafaxine 37.5 mg once daily for 7 days followed by 75mg once daily for 5 weeks.
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Number and severity of hot flashes
时间窗: 15 weeks total
Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.
次要结局
- Sexual function(15 weeks total)
- Sleep quality(15 weeks total)
- Adverse effects of treatments(15 weeks total)
- Anxiety and depression(15 weeks total)
- Adherence(15 weeks total)
- Quality of life and health status(15 weeks total)
- Cognitive function(15 weeks total)
- Preference(15 weeks total)