NCT02385656Unknown4 期
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- severity of fatigue (Brief Fatigue Inventory)
研究概览
简要总结
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.
详细描述
This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solid cancer patient
- •age of 20-65 years old
- •subjects who scored =4 or >4 on the Brief Fatigue Inventory
- •subjects with informed consent
排除标准
- •metastatic cancer(stage IV)
- •with psychotic symptoms such as delusion and hallucination or with suicidal risk
- •with delirium or dementia
- •current medication of cognitive enhancer or psychostimulant uncontrolled medical illness
- •current medications that are contraindicated or not recommended for co-administration with modafinil
研究组 & 干预措施
Intervention group
Experimental
Subjects who take modafinil for cancer-related fatigue for 4 weeks.
干预措施: Modafinil (Drug)
结局指标
主要结局
severity of fatigue (Brief Fatigue Inventory)
时间窗: 4 weeks
Brief Fatigue Inventory
次要结局
未报告次要终点
研究者
In-Young Yoon
Professor
Seoul National University Bundang Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain CancerBrain and Central Nervous System TumorsCognitive/Functional EffectsFatigueNCT00052286Jonsson Comprehensive Cancer Center29
已完成
1 期
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain InjuryFatigueNCT00702637Craig Hospital60
已完成
3 期
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)Breast CancerProstatic NeoplasmsNCT00917748Sanofi84
已完成
1 期
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)FatiguePrimary Biliary CirrhosisNCT00943176Mayo Clinic40
招募中
不适用
The efficacy and tolerability of modafinil for fatigue and daytime sleepiness in cancer patients: preliminary studyKCT0001412Seoul National University Bundang Hospital20