NCT00070161已完成2 期
Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain.
PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.
详细描述
OBJECTIVES:
Primary
- Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration.
Secondary
- Determine the toxicity of these drugs in these patients.
- Determine the quality of life of patients treated with these drugs.
- Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 primary brain tumor or brain metastases, meeting 1 of the following criteria:
- •No radiographic evidence of disease
- •Stable disease, defined as no tumor progression within the past 3 months
- •Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 30 weeks
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Concurrent steroid therapy allowed if on stable or decreasing dose
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent cranial radiotherapy
- •No concurrent surgery
- •More than 3 months since prior donepezil or EGb761
- •No concurrent donepezil (group 2 only)
- •No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03)
- •No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only)
- •No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine)
- •No other concurrent therapy
排除标准
- 未提供
研究者
研究点 (4)
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