Novel interventions for chemotherapy-induced neuropathy

针对化疗引起的神经病变的新干预措施

• 批准号: 10501576
• 负责人: Maryam B. Lustberg
• 金额: $ 3.88万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10501576
• 关键词: ARNT gene; Acoustic Stimulation; Address; Aging; Argentine; Brain region; Breast Cancer survivor; Cardiovascular system; Caregivers; Dancing; Data; Dopamine; Dose-Limiting; Equilibrium; Fatigue; Functional disorder; Future; Goals; Home; Impairment; Individual; Intervention; Moods; Motivation; Musculoskeletal Equilibrium; Music; Nervous System Trauma; Neuropathy; Pain; Patient Outcomes Assessments; Patients; Periodicity; Persons; Phase; Physical activity; Pilot Projects; Prevention; Quality of life; Randomized; Randomized Clinical Trials; Regulation; Reporting; Research; Research Personnel; Sample Size; Sensory; Survivors; Symptoms; Testing; Training; Training Programs; cancer therapy; cardiovascular fitness; chemotherapy induced neuropathy; evidence base; exercise program; experience; fall risk; improved; innovation; intrinsic motivation; locomotor control; motor control; neurophysiology; novel; patient oriented; reduce symptoms; restoration; satisfaction; social; survivorship; systemic inflammatory response; treatment center

Project Abstract: Cancer treatment causes dose-limiting sensory symptoms and postural control dysfunction (neuropathy) in up to 80% of breast cancer (BC) survivors, yet non-invasive treatments to restore motor control remain underdeveloped. To restore mobility, interventions that address motor control, patient-reported symptoms, and motivation to participate - in combination - are most likely to succeed. Thus, we propose to test effect of partnered Adapted Argentine Tango (Tango) as an ideal intervention to simultaneously target restoration of mobility and alleviation of symptoms through socially-motivated participation. Tango is moderate intensity social dance, adapted for individuals with mobility deficits, that delivers sensorimotor and cardiovascular training to rhythmic music. Tango promotes survivor participation through creative engagement and caregiver inclusion. Previous research by the investigators established Tango as feasible for aging survivors (up to 82 years) to engage in with high satisfaction and effects to neuropathy-related motor control deficits. Therefore, we propose to conduct a Phase II, randomized clinical trial investigating Tango in 52 BC survivors with neuropathy. Our overarching hypothesis is that Tango is associated with improved postural control (primary) as well as improved balance, locomotor control and patient-reported outcomes (PROs) (secondary) relative to an evidence- based home exercise program (HEX). Our rationale: Tango combines the effects of rhythmic auditory stimulation on postural control regulation; physical activity practice on neuromotor control and cardiovascular fitness; with social motivation to participate in treatment. Our long-term goal is to optimize prevention and treatment of neuropathy utilizing non-invasive, patient-centered treatment to improve motor control more definitively and more quickly for more people. Toward this goal, BC survivors with balance deficits associated with neuropathy will be randomly assigned to Tango or HEX training, twice per week, for an 8 week period. Using an intent-to-treat approach, this innovative pilot study will determine impact of Tango on (AIM1) 1) postural control; 2) balance; 3) PROs including sensory symptoms, pain, fatigue, mood, quality of life, and intrinsic motivation; as well as explore (AIM2) 4) locomotor control. These data will enable us to establish effect sizes and estimate sample size for a future trial that will investigate relationship of neuromotor control and PROs to structural changes in regions of the brain involved in motor control and planning, central dopamine regulation, and systemic inflammation among individuals with neurotrauma.

项目摘要：癌症治疗导致限制剂量的感觉症状和姿势控制功能障碍 （神经病）最多80％的乳腺癌（BC）幸存者，但无创治疗方法可恢复运动控制 保持欠发达。为了恢复活动能力，解决运动控制的干预措施，病情报告 症状和参与的动力 - 结合 - 最有可能成功。因此，我们建议测试 合作的改编的阿根廷探戈（Tango）的效果是同时靶向恢复的理想干预措施 通过社会动机的参与来促进流动性和减轻症状。探戈是中等强度 社交舞蹈，适合流动性障碍的人，可以提供感觉运动和心血管训练 节奏音乐。探戈通过创造性参与和护理人员包容促进幸存者的参与。 研究人员先前的研究确定了探戈对老龄幸存者（长达82年）的可行 对与神经病相关的运动控制缺陷保持高满意和影响。因此，我们提出 为了进行II期，随机临床试验研究了公元前52个神经病幸存者的探戈。 我们的总体假设是探戈与改善的姿势控制（主要）以及 相对于证据，改善平衡，运动控制和患者报告的结局（Pros）（次要） 基于家庭锻炼计划（HEX）。我们的理由：探戈结合了节奏听觉的影响 刺激姿势控制调节；神经运动控制和心血管的体育锻炼实践 健康;随着社会动机参加治疗。我们的长期目标是优化预防和 利用非侵入性，以患者为中心的治疗来改善运动控制的神经病治疗更多 对于更多的人来说，绝对更快。达到这个目标，卑诗省幸存者与平衡不足有关 神经病变将随机分配给探戈或十六进制训练，每周两次，为期8周。使用 这项创新的试点研究是一种意图对治疗方法，将确定探戈对（AIM1）1）姿势的影响 控制; 2）平衡； 3）优点包括感觉症状，疼痛，疲劳，情绪，生活质量和内在 动机;以及探索（AIM2）4）运动控制。这些数据将使我们能够建立效果大小 并估算未来试验的样本量，该试验将调查神经运动控制和专业人士的关系 与运动控制和计划有关的大脑区域的结构变化，中央多巴胺调节， 神经瘤患者的系统性炎症。