A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Neurocognitive functioning
研究概览
简要总结
RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.
PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
详细描述
OBJECTIVES:
- Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
- Determine the safety of this drug in these patients.
- Compare quality of life of patients treated with 2 different doses of this drug.
OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.
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Randomized phase:
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Arm I: Patients receive oral high-dose modafinil twice daily.
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Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
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Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
- •Nonmalignant cerebral tumors also allowed
- •Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
- •Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale
- •Age 21 to 65
- •Able to speak English
- •Capable of completing self-rating scales and one-on-one psychometric tests
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed
- •Concurrent glucocorticoids (e.g., dexamethasone) allowed
- •Concurrent tamoxifen allowed
- •At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
- •Concurrent anticonvulsants allowed
- •Concurrent isotretinoin allowed
排除标准
- •Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal.
- •Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl.
- •severe cognitive impairment
- •other terminal illness
- •emergency patient
- •institutional resident
- •prisoner or parolee
- •UCLA students or staff
- •pregnant or nursing
- •concurrent irinotecan
- •concurrent participation in UCLA experimental chemotherapy trials
- •prior modafinil
- •concurrent experimental anticancer medication
- •concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
研究组 & 干预措施
drug dosage 1
- Arm I: Patients receive oral high-dose modafinil twice daily.
干预措施: modafinil (Drug)
drug dosage 2
- Arm II: Patients receive oral low-dose modafinil twice daily.
干预措施: modafinil (Drug)
结局指标
主要结局
Neurocognitive functioning
时间窗: at baseline and weeks 1, 3, 4, 8, and 10
次要结局
- Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change.(at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10)