A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCL in brain tumor patients receiving radiation therapy
A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCL in brain tumor patients receiving radiation therapy
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DOI：
10.1016/j.ijrobp.2007.05.076
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发表时间：
2007-12-01
影响因子：
7
通讯作者：
Shaw, Edward G.
中科院分区：
文献类型：
--
作者：
Butler, Jerome M., Jr.;Case, L. Douglas;Shaw, Edward G.
目的：脑肿瘤患者的生活质量（QOL）和神经认知功能受到疾病症状和脑放射治疗（RT）的负面影响。我们评估了预防性d-苏型-哌甲酯盐酸盐（d-MPH），中枢神经系统（CNS）兴奋剂对接受RT的患者的生活质量和认知功能的影响。方法和材料：68例原发性或转移性脑肿瘤患者随机分配接受d-MPH或安慰剂。d-MPH的起始剂量为5 mg，每日两次（b.i.d.）并递增5 mg b.i.d.。最多15 mg b.i.d.安慰剂以一粒药丸b.i.d.给药。每日两次三片主要结局是疲劳。患者在基线、放疗结束时和脑放疗后4、8和12周使用癌症治疗功能评估与脑和疲劳（FACIT-F）子量表以及流行病学研究中心量表和简易精神状态检查进行评估。基线时，d-MPH组的平均疲劳子量表评分为34.7，安慰剂组为33.3（p = 0.61）。在脑RT完成后8周，患者组之间的疲劳没有差异。d-MPH组和安慰剂组的平均疲劳子量表评分的校正最小二乘估计值分别为33.7和35.6（p = 0.64）。两个治疗组之间的次要结果没有差异。结论：在接受RT的脑肿瘤患者中预防性使用d-MPH并没有导致生活质量的改善。(c)2007爱思唯尔公司
Purpose: The quality of life (QOL) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy (RT). We assessed the effect of prophylactic d-threo-methylphenidate HCL (d-MPH), a central nervous system (CNS) stimulant on QOL and cognitive function in patients undergoing RT.Methods and Materials: Sixty-eight patients with primary or metastatic brain tumors were randomly assigned to receive d-MPH or placebo. The starting dose of d-MPH was 5 mg twice daily (b.i.d.) and was escalated by 5 mg b.i.d. to a maximum of 15 mg b.i.d. The placebo was administered as one pill b.i.d. escalating three pills b.i.d. The primary outcome was fatigue. Patients were assessed at baseline, the end of radiation therapy, and 4, 8, and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT-F) subscales, as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam.Results: The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm (p = 0.61). At 8 weeks after the completion of brain RT, there was no difference in fatigue between patient groups. The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm (p = 0.64). Secondary outcomes were not different between the two treatment arms.Conclusions: Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL. (c) 2007 Elsevier Inc.