NCT01032200已完成2 期
A Feasibility Study of Armodafinil for Brain Radiation-Induced 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
- 54
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.
PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.
详细描述
OBJECTIVES:
Primary
- To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.
- To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.
Secondary
- To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.
- To estimate the rates of toxicity and adverse events associated with armodafinil.
- To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)
- •No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:
- •Ongoing or active infection
- •Chronic renal insufficiency
- •Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal)
- •Extreme social situations (e.g., transportation issues that would preclude study compliance)
- •Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG
- •No history of allergic reaction attributed to modafinil or armodafinil
- •No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior fractionated external-beam cranial radiotherapy
- •More than 30 days since prior monoamine oxidate inhibitors or investigational drugs
- •More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs
- •At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife)
- •No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL)
- •Concurrent chemotherapy allowed
- •Concurrent hormonal therapy for other malignancies allowed
- •No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy
- •No concurrent clopidogrel bisulfate (Plavix)
研究组 & 干预措施
Arm I - Armodafinil
Experimental
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
干预措施: Armodafinil (Drug)
Arm II - Placebo
Placebo Comparator
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
干预措施: placebo (Other)
结局指标
主要结局
Retention
时间窗: 4 weeks post-RT (approximately 3 months post randomization)
Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
Adherence
时间窗: 4 weeks post-RT (approximately 3 months post randomization)
Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)
次要结局
- Fatigue(4 weeks post-RT)
- Sleepiness(4 weeks post-RT)
- HVLT-IR(4 weeks post-RT)
研究者
研究点 (1)
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