NL-OMON52805已完成4 期
Effect of a reduced dose on cognitive side effects of enzalutamide in frail (m)CRPC patients - REDOSE
Afdeling Apotheek0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Frail* male patients with prostate cancer who will start treatment with
- •enzalutamide
- •(* Frail is defined as a score on the comprehensive G8 assessment with cut-off
- •<12 points
- •and score >grade 1 for Central Nervous Disorders according to the Common
- •Toxicity Criteria Adverse Event (CTCAE) criteria, of one of the following:
- •Fatigue, Concentration impairment, cognitive disturbance, amnesia, depressed
- •level of consciousness, memory impairment, hypersomnia.)
- •- 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
- •- Patients 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
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
- •- 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
相似试验
进行中（未招募）
1 期
Can side effects of enzalutamide be prevented by using a reduced dose for frail (m)CRPC patients?(Metastatic) Castration Resistant Prostate Cancer (mCRPC)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000779-33-NLRadboud University Medical Center50
已完成
不适用
Comparison of efficacy and cognitive side effects of bifrontal and bitemporal electroconvulsive therapy (ECT) for major depressioElectrode placement in electroconvulsive therapyMajor depressionMental Health - DepressionACTRN12610000177055IPSEMG/ Hospital Governador Israel Pinheiro31
已完成
不适用
Comparison of Effects and side effects between two variations of treatment modalities in SchizophreniaCTRI/2020/11/029184Dr Sukriti Mukherjee60
招募中
3 期
Can an acute dosage of Bacopa Monniera (brahmi) improve cognition, cardiovascular function and stress in a healthy older populatioCognitive function in healthy older individualsCardiovascular function in healthy older individualsStressAlternative and Complementary Medicine - Herbal remediesCardiovascular - Normal development and function of the cardiovascular systemMental Health - Studies of normal psychology, cognitive function and behaviourACTRN12609000717257Swinburne University32
已完成
3 期
Can an acute dosage of Bacopa Monniera (brahmi) improve cognition, cardiovascular function and stress in an elderly populatioCognitive function in healthy elderly individualsCardiovascular function in healthy elderly individualsStressAlternative and Complementary Medicine - Herbal remediesCardiovascular - Normal development and function of the cardiovascular systemMental Health - Studies of normal psychology, cognitive function and behaviourACTRN12611001230943Swinburne University20