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: 10218923
• 负责人: Maryam B. Lustberg
• 金额: $ 22.95万
• 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/10218923
• 关键词: ARNT gene; Acoustic Stimulation; Address; Aging; Antidepressive Agents; Area; Argentine; Brain region; Breast Cancer Treatment; Breast Cancer survivor; Cancer Survivor; Cardiovascular system; Caregivers; Caring; Control Groups; Dancing; Data; Degenerative Disorder; Disease; Dopamine; Dose-Limiting; Equilibrium; Exercise; Exposure to; Failure; Fatigue; Feasibility Studies; Functional disorder; Future; Gait; Goals; Health; Home; Impairment; Incidence; Individual; Intervention; Knowledge; Measurable; Measurement; Measures; Moods; Motivation; Motor; Musculoskeletal Equilibrium; Music; Nervous System Trauma; Neuropathy; Oral; Outcome; Pain; Parkinson Disease; Patient Care; Patient Outcomes Assessments; Patients; Periodicity; Persons; Pharmaceutical Preparations; Phase; Physical activity; Pilot Projects; Prevention; Quality of life; Randomized; Randomized Clinical Trials; Regulation; Reporting; Research; Research Personnel; Sample Size; Sensory; Speed; Structure; Survivors; Symptoms; Testing; Toxic effect; Training; Training Programs; Walking; Work; age related; aging population; axon regeneration; base; cancer therapy; cardiovascular fitness; chemotherapy; chemotherapy induced neuropathy; duloxetine; evidence base; exercise program; experience; fall risk; falls; improved; innovation; intrinsic motivation; locomotor control; member; motor control; multidisciplinary; neurophysiology; novel; painful neuropathy; patient oriented; post intervention; pressure; primary endpoint; prospective; randomized controlled study; reduce symptoms; restoration; satisfaction; side effect; social; social stigma; 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：癌症治疗导致剂量限制性感觉症状和姿势控制功能障碍 高达 80% 的乳腺癌 (BC) 幸存者会出现（神经病变），但非侵入性治疗可恢复运动控制 仍然不发达。为了恢复活动能力，针对运动控制的干预措施，患者报告 症状和参与动机相结合最有可能成功。因此，我们建议测试 配合阿根廷探戈（Tango）作为同时目标恢复的理想干预措施的效果 通过社会动机的参与来提高活动能力和缓解症状。探戈是中等强度 适合行动不便人士的社交舞，提供感觉运动和心血管训练 到有节奏的音乐。 Tango 通过创造性的参与和护理人员的包容来促进幸存者的参与。 研究人员之前的研究表明 Tango 对于老年幸存者（82 岁以下）来说是可行的 对神经病相关的运动控制缺陷有很高的满意度和效果。因此，我们建议 进行一项 II 期随机临床试验，对 52 名患有神经病的 BC 幸存者进行调查。 我们的总体假设是 Tango 与改善姿势控制（主要）以及 相对于证据而言，改善平衡、运动控制和患者报告的结果（PRO）（次要） 基于家庭锻炼计划（HEX）。我们的理由：Tango 结合了有节奏的听觉效果 对姿势控制调节的刺激；神经运动控制和心血管的身体活动练习 健康;具有参与治疗的社会动机。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来治疗神经病 为更多人明确、更快地提供服务。为了实现这一目标，具有平衡缺陷的 BC 幸存者 患有神经病的患者将被随机分配接受 Tango 或 HEX 训练，每周两次，为期 8 周。使用 这项创新试点研究采用意向治疗方法，将确定 Tango 对 (AIM1) 1) 姿势的影响 控制; 2）平衡； 3) PROs 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确定效应大小 并估计未来试验的样本量，该试验将研究神经运动控制和 PRO 与 涉及运动控制和计划、中枢多巴胺调节的大脑区域的结构变化， 以及神经外伤患者的全身炎症。