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）幸存者患有神经病，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，患者报告的针对运动控制的干预措施 症状和参与的动机-结合起来-最有可能成功。因此，我们建议测试 合作适应阿根廷探戈（探戈）作为一个理想的干预措施，同时目标恢复的效果 的流动性和减轻症状通过社会动机的参与。探戈是中等强度的 社交舞，适合行动不便的人，提供感觉运动和心血管训练 有节奏的音乐。Tango通过创造性的参与和照顾者的参与促进幸存者的参与。 研究人员先前的研究证实，探戈对老年幸存者（最多82岁）是可行的， 从事高满意度和影响神经病相关的运动控制缺陷。所以我们提出 进行一项II期随机临床试验，在52名患有神经病的BC幸存者中研究Tango。 我们的总体假设是，探戈与改善姿势控制（主要）以及 与证据相比，平衡、运动控制和患者报告结局（PRO）（次要）得到改善， 家庭锻炼计划（HEX）我们的理论基础：探戈结合了节奏听觉的效果， 对姿势控制调节刺激;对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， 利用非侵入性、以患者为中心的治疗来治疗神经病，以改善运动控制 为更多的人提供更快更明确的服务为了实现这一目标，BC幸存者与平衡赤字相关 神经病患者将被随机分配到Tango或HEX训练组，每周两次，持续8周。使用 作为一种意向治疗方法，这项创新的试点研究将确定Tango对（AIM 1）1）姿势的影响 控制; 2）平衡; 3）PRO，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（AIM 2）4）运动控制。这些数据将使我们能够建立效应大小 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 涉及运动控制和规划，中枢多巴胺调节， 以及神经创伤患者的全身性炎症。