NCT00042848已完成3 期
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 837
- 试验地点
- 35
- 主要终点
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
研究概览
简要总结
RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known.
PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
- Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy.
- Assess the relationship between depression and fatigue in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily.
- Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral placebo once daily.
Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer
- •Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy
- •Each course of chemotherapy must be at least 2 weeks in duration
- •No concurrent radiotherapy or interferon therapy
- •Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Not specified
- •No uncontrolled anemia
- •Not specified
- •Cardiovascular
- •No history of clinically significant cardiac disease, including any of the following:
- •Unstable angina
- •Left ventricular hypertrophy
- •Ischemic echocardiogram changes
- •Chest pain
- •Arrhythmia
- •Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)
- •No uncontrolled hypertension
- •Gastrointestinal
- •Able to swallow medication
- •No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
- •No severe headaches
- •No glaucoma
- •No seizure disorder
- •No narcolepsy
- •No psychotic disorder
- •No Tourette's syndrome
- •No alcohol or drug abuse
- •Not pregnant or nursing
- •Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •No concurrent chronic corticosteroids
- •Radiotherapy
- •See Disease Characteristics
- •Not specified
- •No prior modafinil
- •At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)
- •No concurrent alcohol
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
次要结局
- Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4
研究者
Gary Morrow
Director, URCC NCORP Research Base
University of Rochester NCORP Research Base
研究点 (35)
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