Home-Based Physical Activity Intervention for Taxane-Induced CIPN

项目摘要/摘要 持续的紫杉烷诱导的周围神经病变是乳腺癌的一个显著的剂量限制性毒性 用化疗进行治疗。紫杉烷化疗所致感觉和运动神经元功能障碍 通过诱导线粒体和血管功能障碍导致感觉和运动神经病，损害 身体功能和生活质量。这项由两组组成的随机对照试验的具体目标是：1)测试16- 周步态和平衡训练加上阻力练习，与教育注意力控制条件进行比较 减少紫杉烷诱导的周围神经病症状的严重程度；和2)评估 步态/平衡、下肢肌力、感觉(腓肠)和运动(腓)神经的差异 接受步态/平衡训练加抵抗的患者之间的传导和生活质量 锻炼计划，与那些在教育注意力控制条件下控制年龄、BMI、 紫杉烷周期/间隔，神经性疼痛，药物(疼痛或针对神经疾病的药物)，电流 抵抗力练习，并经历跌倒/接近跌倒。这项随机对照试验将纳入312名患者的样本 完成了含有紫杉烷的乳腺癌化疗方案&1年后有神经病变评分的患者 在CIPN视觉模拟标尺上。评估下肢肌力、步态/平衡、神经 将在基线(之前)收集传导、神经病症状和生活质量(QOL) 随机化)；4周；8周；12周；和16周。神经传导研究将在 基线(干预前)和16周(干预结束)。年龄、体重指数、紫杉烷的控制变量 周期/间歇，目前的阻力运动将收集在基线。关于神经性疼痛的数据， 药物(针对疼痛或神经病变的药物)以及跌倒/险些跌倒将在每个数据中进行评估 采集时间点为其对因变量的影响。在基线数据收集之后， 参与者将被随机分配到步态/平衡加阻力训练干预或 教育注意对照组。数据分析将包括意图处理分析策略 利用通用的混合建模框架。

Project Summary/Abstract Persistent taxane-induced peripheral neuropathy is a significant dose-limiting toxicity of breast cancer treatment with chemotherapy. The sensory and motor neuron dysfunction accompanying taxane chemotherapy results in sensory and motor neuropathy by inducing both mitochondrial and vascular dysfunction, impairing physical functioning, and quality of life. The specific aims of this 2-group RCT are: 1)to test the efficacy of a 16- week gait and balance training plus resistance exercise, compared to an educational attention control condition in decreasing the severity of taxane-induced peripheral neuropathy symptoms; and 2) to evaluate for differences in gait/balance, lower extremity muscle strength, sensory (sural) and motor (peroneal) nerve conduction, and quality of life (QOL) between patients who receive the gait/balance training plus resistance exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles/interval, neuropathic pain, medications (pain or neuropathy-specific medication), current resistance exercise, and falls/near falls experienced. This RCT will enroll a sample of 312 patients who completed a taxane-containing chemotherapy regimen for breast cancer > 1 year who have a neuropathy score of > 3 on a CIPN visual analog scale. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be collected at baseline (prior to randomization); 4 weeks; 8 weeks; 12 weeks; and 16 weeks. Nerve conduction studies will be performed at baseline (pre-intervention) and 16 weeks (end of intervention). Control variables of age, BMI, taxane cycles/interval, and current resistance exercise will be collected at baseline. Data regarding neuropathic pain, medications (pain or neuropathy-specific medication), and falls/near falls will be assessed at each data collection time point for their influence upon the dependent variables. Following baseline data collection, participants will be randomly assigned to the combination gait/balance plus resistance training intervention or the education attention control group. Data analysis will consist of an intention to treat analytic strategy utilizing a generalized mixed modeling framework.