NCT00112515Unknown不适用
Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
研究概览
简要总结
RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.
PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of modafinil in cancer patients.
- Determine the efficacy of this drug, in terms of improving fatigue, in these patients.
Secondary
- Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer
- •Brief Fatigue Inventory score ≥ 4
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No history of left ventricular hypertrophy
- •No history of ischemic ECG changes
- •No history of chest pain
- •No history of arrhythmia
- •No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use
- •Not pregnant or nursing
- •Negative pregnancy test
- •Thyroid stimulating hormone normal
- •No known hypersensitivity to modafinil
- •No history of psychotic disorder and/or active psychosis
- •No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Concurrent thalidomide allowed
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •Concurrent narcotics, phenothiazines, or benzodiazepines allowed
- •No other concurrent investigational therapy
排除标准
- 未提供
结局指标
主要结局
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
次要结局
- Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
- Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
- Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
- Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
- Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
- Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
- Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
- Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
研究者
研究点 (2)
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