Home-Based Physical Activity Intervention for Taxane-Induced CIPN

针对紫杉烷诱发 CIPN 的家庭身体活动干预

• 批准号: 10411399
• 负责人: CONSTANCE G. VISOVSKY
• 金额: $ 16.63万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10411399
• 关键词: Address; Adenosine Triphosphate; Affect; Afferent Neurons; Aftercare; Age; Analgesics; Animals; Attenuated; Axon; Balance training; Blood Vessels; Blood flow; Body mass index; Breast Cancer Treatment; Cancer Survivorship; Cell Death; Chemotherapy-Oncologic Procedure; Chronic; Clinical; Control Groups; Data; Data Analyses; Data Collection; Development; Dose; Dose-Limiting; Education; Educational Intervention; Endothelial Cells; Endothelium; Enrollment; Equilibrium; Evidence based intervention; Exercise; Functional disorder; Gait; Glycolysis; Home; Human; Impairment; Intention; Intervention; Lead; Lower Extremity; Mitochondria; Mitochondrial Proteins; Modeling; Motor; Motor Neurons; Muscle; Muscle Cells; Muscle Weakness; Nerve; Neural Conduction; Neurons; Neuropathy; Numbness; Nutrient; Outcome; Oxygen; Paclitaxel; Pain; Participant; Patients; Peripheral Nerves; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Physical Function; Prevention strategy; Proprioception; Protein Biosynthesis; Quality of life; Randomized; Reporting; Resistance; Rodent; Sampling; Sensory; Sensory Manifestations; Severities; Spinal Ganglia; Symptoms; Testing; Time; Touch sensation; Toxic effect; Translating; Vasa Nervorum; Vascular Diseases; Vascular Endothelial Growth Factors; Vasodilation; Visual; analog; arteriole; attentional control; base; chemotherapy; clinical practice; control trial; docetaxel; efficacy testing; equilibration disorder; evidence base; exercise intervention; exercise program; experience; fall injury; fall risk; falls; functional disability; gait rehabilitation; home test; improved; malignant breast neoplasm; mitochondrial dysfunction; motor symptom; muscle strength; nerve conduction study; neurotoxic; painful neuropathy; peroneal nerve; prevent; programs; reduced muscle strength; resistance exercise; strength training; sural; taxane; treatment strategy; vibration

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.

项目总结/摘要 持续性紫杉烷诱导的周围神经病变是乳腺癌的一种显著的剂量限制性毒性 化疗治疗。紫杉烷类化疗引起的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， 身体机能和生活质量。该2组RCT的具体目的是：1）测试16- 一周的步态和平衡训练加阻力运动，与教育注意力控制条件相比 降低紫杉烷诱导的周围神经病变症状的严重程度; 2）评估 步态/平衡、下肢肌力、感觉（腓肠）和运动（腓总神经）神经的差异 接受步态/平衡训练加阻力的患者之间的传导和生活质量（QOL） 运动计划，与那些在控制年龄，BMI， 紫杉烷周期/间隔，神经性疼痛，药物（疼痛或神经病特异性药物），当前 阻力练习，以及经历过福尔斯/近福尔斯。该RCT将招募312例患者样本， 完成含紫杉烷的乳腺癌化疗方案> 1年，有神经病变评分 在CIPN视觉模拟量表上> 3。下肢肌力、步态/平衡、神经评估 将在基线时（治疗前）收集神经传导、神经病变症状和生活质量（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、BMI、紫杉烷的控制变量 将在基线时收集周期/间隔和当前抗阻运动。关于神经性疼痛的数据， 药物（疼痛或神经病特异性药物）和福尔斯/接近福尔斯将在每次数据时进行评估 收集时间点对因变量的影响。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的组合，或 教育注意力控制组。数据分析将包括一个意向处理分析策略 利用广义混合建模框架。