NCT00758407已完成2 期
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
研究概览
简要总结
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of Cancer
- •Karnofsky Index >=70
- •outpatient
- •patient are able to give informed consent
排除标准
- •treatment with psychostimulants in the past two weeks before screening
- •active tumor disease
- •depression (HADS >10)
- •cachexia (BMI <18kg/m2)
- •clinically relevant kidney disorders
- •clinically relevant liver disorder
- •pathological ECG-finding
- •high blood pressure
- •occlusive arterial disease
- •angina pectoris
- •cardiac arrhythmias
- •post heart-attack status
- •post stroke status
- •known elevated intra-ocular pressure
- •known enlarged prostates
- •latent and manifest hyperthyreosis
- •alcohol, medication or drug dependency in the past six months or manifest drug abuse
- •participation in a clinical study within the past 30 days
- •participation in this study at an earlier point in time
- •simultaneous participation in another clinical trial
- •women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
- •pregnancy (positive pregnancy test) or lactation period
研究组 & 干预措施
1
Active Comparator
干预措施: Methylphenidate hydrochloride (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
时间窗: 6 weeks
次要结局
- Quality of Life (EORTC-QLQ C30)(6 weeks)
研究者
研究点 (6)
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