The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial
The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial
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DOI：
10.1093/neuonc/not102
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发表时间：
2013-10-01
期刊：
影响因子：
15.9
通讯作者：
Klein, Martin
中科院分区：
文献类型：
--
作者：
Boele, Florien W.;Douw, Linda;Klein, Martin
背景。疲劳、认知缺陷和抑郁是经常被报道但往往治疗不足的症状，这些症状会严重影响原发性脑肿瘤（pbt）患者的日常生活。为了评估精神兴奋剂莫达非尼对PBT患者疲劳、抑郁、健康相关生活质量（HRQOL）和认知功能的影响，我们进行了一项多中心、双盲安慰剂对照交叉试验。患者随机接受莫达非尼治疗6周（高达400mg /天）或安慰剂治疗6周。在1周的洗脱期后，给予相反的治疗。评估在基线和第一和第二种情况后立即进行。患者完成疲劳自述问卷（Checklist Individual Strength [CIS]）、抑郁自述问卷（centers for epidemiology Studies抑郁量表[CES-D]）、HRQOL （Short-Form Health Survey [SF-36]）和自我认知功能自述问卷（Medical Outcomes Study [MOS]）。他们还接受了全面的神经认知测试。总共有37名患者参与。与基线相比，患者在莫达非尼组（P = 0.010和P = 0.021）和安慰剂组（P < 0.001和P = 0.027）均报告了较低的疲劳严重程度（CIS）和较好的动力（CIS）。身体健康（SF-36 physical Component Summary score; P = .001和P = .008）、工作记忆（P = .040和P = .043）和信息处理能力（P = .036和P = .040）也是如此。两组患者的抑郁症状均未得到改善。莫达非尼在症状管理方面没有超过安慰剂的效果。患者累积缓慢，相对较多的患者在试验期间退出，主要是由于副作用。其他，最好是非药物干预研究，应考虑改善PBT患者的症状管理。
Background. Fatigue, cognitive deficits, and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue, depression, health-related quality of life (HRQOL), and cognitive functioning in PBT patients, we performed a multicenter, double-blind placebo-controlled crossover trial.Methods. Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period, the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]), depression (Center for Epidemiologic Studies Depression Scale [CES-D]), HRQOL (Short-Form Health Survey [SF-36]), and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing.Results. In total, 37 patients participated. Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021, respectively) and the placebo condition (P < .001 and P = .027, respectively). The same held for physical health (SF-36 Physical Component Summary score; P = .001 and P = .008, respectively), working memory (P = .040 and P = .043), and information processing capacity (P = .036 and P = .040). No improvement in depressive symptoms was found in either condition.Conclusions. Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow, and relatively many patients dropped out during the trial, due mostly to side effects. Other, preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients.