NCT00031798终止3 期
A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors.
PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.
详细描述
OBJECTIVES:
- Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors.
- Determine the effect of this drug on the quality of life of these patients.
- Determine the effect of this drug on depression in these patients.
- Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified by tumor type (primary vs metastatic), treatment (radiotherapy vs radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs 90% or 100%). Patients are randomized to one of two treatment arms.
All patients undergo radiotherapy over weeks 1-4.
- Arm I: Patients receive oral d-methylphenidate twice daily on weeks 1-12.
- Arm II: Patients receive oral placebo twice daily on weeks 1-12. In both arms, quality of life is assessed at baseline, at the end of radiotherapy, and at 4, 8, and 12 weeks after radiotherapy.
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:
- •Histologically confirmed metastatic brain tumor OR
- •Histologically confirmed primary brain tumor
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Low-grade glioma
- •Meningioma
- •Ependymoma
- •Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC ≥ 1,500/mm^3
- •Hemoglobin ≥ 10.0 g/dL
- •Platelet count ≥ 75,000/mm^3
- •Not specified
- •Not specified
- •Cardiovascular:
- •No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other serious medical or psychiatric illness that would preclude study participation
- •No hypersensitivity to study drug
- •No history of steroid psychosis
- •No family history of or active Tourette's Syndrome
- •No prior or active glaucoma
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior or concurrent chemotherapy allowed
- •Endocrine therapy:
- •Concurrent steroids allowed
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy allowed except to brain (including stereotactic radiosurgery)
- •No concurrent craniospinal axis radiotherapy
- •Not specified
- •No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse
- •No concurrent anti-depressants
排除标准
- 未提供
研究者
研究点 (7)
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