SLEEP, FATIGUE, AND DEXAMETHOSONE IN CHILDHOOD CANCER

越来越多的证据表明，将地塞米松添加到 诊断为淋巴细胞性白血病的儿童和青少年的治疗 有助于更积极的长期结果，如较低的 脑膜白血病。地塞米松的重大积极贡献 并不是在发生时没有不良反应，包括缺血性坏死。狂热 精神错乱，以及异常的睡眠和疲劳。这些不利影响可能是 与系统性接触中的个体间变异性有关 地塞米松，如果是这样的话，不良反应可能会成为行为 患者对给药计划的敏感性指标。以确定是否 地塞米松给药计划需要个性化，以最大限度地减少不良反应 在维持抗白血病作用的同时，两者之间的关系 必须确定个体间的可变性和不利影响。这个 这项两个现场研究的总体目的是确定 地塞米松全身暴露与患者睡眠和疲劳的比较 连续两个5天的患者睡眠和疲劳的多个指标 停用地塞米松和停用地塞米松的持续治疗期间。大致 134名FISK低或标准的儿童和青少年都将佩戴WIST 连续两个为期5天的学习期间的活动图，并将完成 第二天和第五天电话采访中的自我报告疲劳问卷 这两个研究阶段。他们的父母将完成睡眠日记和疲惫 在两个学习期间的第二天和第五天关于他们孩子的问卷调查 睡眠和疲劳模式。此外，在地塞米松5天的第一天 在研究期间，患者将在治疗前和治疗前连续采集血样 早上服用地塞米松后。将对这些样品进行分析以确定 地塞米松药代动力学和基因多态性。使用这些数据，我们 将检验地塞米松导致睡眠异常的假说 儿童和青少年的疲劳增加与ALL，并改变了 睡眠和疲劳与药物的药代动力学有关。我们的研究 研究结果将阐明睡眠效率和疲劳之间的关系， 以及睡眠、疲劳和全身暴露于地塞米松之间。

Mounting evidence indicates that adding dexamethasone to the therapy for children and adolescents diagnosed with lymphoblastic leukernia contributes to more positive long-term outcomes such as lower rates of meningeal leukemia. The significant positive contributions of dexamethasone have not occurred without adverse effects including avascular necrosis. mania and psychosis, and aberrant sleep and fatigue. These adverse effects could be related to inter-individual variability in the systemic exposure to dexamethasone and if so, the adverse effects could serve as behavioral indicators of patient sensitivity to the dosing schedule. To determine whether dexamethasone dosing schedules need to be individualized to minimize adverse effects while maintaining antileukernic effects, the relationship between inter-individual variability and adverse effects must be established. The overall purpose of this two-site study is to determine the relationship between systemic exposure to dexamethasone and patients' sleep and fatigue by comparing multiple indicators of patient sleep and fatigue in two consecutive 5-day periods during Continuation therapy off and on dexatnethasone. Approximately 134 children and adolescents with low or standard fisk ALL will wear a wnist actigraph for the two consecutive 5-day study periods and will complete a self-report fatigue questionnaire during a telephone interview on Days 2 and 5 of both study periods. Their parents will complete a sleep diary and a fatigue questionnaire on Days 2 and 5 of both study periods regarding their child's sleep and fatigue patterns. In addition, on Day I of the on dexamethasone 5-day study period, patients will-have sequential blood samples collected pre- and post- the morning dose of dexamethasone. These samples will be analyzed for dexamethasone pharmacokinetics and genetic polymorphism. Using these data, we will test the hypothesis that dexamethasone contributes to aberrant sleep and increased fatigue in children and adolescents with ALL, and that the altered sleep and fatigue are related to the pharmacokinetics of the drug. Our study findings will explicate the relationship between sleep efficiency and fatigue, and between sleep, fatigue, and systemic exposure to dexamethasone.