NCT00452868已完成早期 1 期
A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
研究概览
简要总结
RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain.
PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.
详细描述
OBJECTIVES:
Primary
- Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy.
Secondary
- Assess health-related quality of life of patients treated with this drug.
- Assess function and quality of life of the families of patients treated with this drug.
- Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug.
- Determine the toxicity of donepezil hydrochloride in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of primary brain tumor
- •No type 2 neurofibromatosis
- •Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
- •Karnofsky or Lansky performance status 70-100%
- •Fertile patients willing to use effective contraception
- •Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
- •Stable weight within the past 6 months with no concern of weight loss
- •Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
- •Able to speak English
- •More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug
排除标准
- •Stereotactic radiosurgery as sole treatment
- •Evidence of disease progression by MRI
- •Pregnant or nursing
- •Attention-deficit/hyperactivity disorder before cancer diagnosis
- •Uncontrolled seizures or uncontrolled endocrinopathies
- •Uncontrolled comorbidities
- •Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
- •Use of concurrent anticholinergic drugs
研究组 & 干预措施
Donepozil
Experimental
Donepezil 5 milligrams a day for 6 weeks
干预措施: Donepezil (Drug)
结局指标
主要结局
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
时间窗: 24 weeks
Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
次要结局
未报告次要终点
研究者
研究点 (2)
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