EUCTR2018-000779-33-NL进行中（未招募）1 期
Effect of a reduced dose on cognitive side effects of enzalutamide in frail (m)CRPC patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •-Frail male patients with PC who will start enzalutamide treatment within label
- •-Age at least 18 years
- •-Patient who are able and willing to give written informed consent prior to screening and enrolment
- •-Patients from whom it is possible to collect blood samples and who are willing to answer the questionnaires
- •-Life expectancy of > 6 months
- •-Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •-Other causes for cognition change:
- •- (change in dose of opioids/sedatives/benzodiazepines) during last 2 weeks before study)
- •-Use of psychostimulantia such as methylphenidate within 1 week of start of study
- •-Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer disease, Parkinson’s disease, psychiatric disorders that affect cognition other than depression or anxiety complaints related to the disease
- •-Active infection or other comorbidities that may contribute to fatigue or cognition change within 4 weeks of study entry
- •-Clinical relevant anaemia
研究者
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