Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in OP HNC

呼吸吞咽训练对 OP HNC 难治性吞咽困难的临床影响

• 批准号: 10329978
• 负责人: BONNIE J MARTIN-HARRIS
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329978
• 关键词: Ablation; Adherence; Adjuvant; Area; Aspiration Pneumonia; Barium swallow; Behavioral; Big Data; Chronic; Clinic; Clinical; Clinical assessments; Computer Analysis; Computer software; Crossover Design; Data; Databases; Deglutition; Deglutition Disorders; Development; Diet; Disease; Eating; Educational Intervention; Elements; Enteral Feeding; Event; Food; Future; General Population; Generations; Goals; Head and Neck Cancer; Health; Health care facility; Home; Impairment; Incidence; Infection; Ingestion; Intake; Intervention; Knowledge; Laboratories; Larynx; Learning; Life; Liquid substance; Maintenance; Malignant Neoplasms; Measurement; Measures; Mechanics; Medical; Methods; Modeling; Motor; Operative Surgical Procedures; Oral; Oropharyngeal; Outcome; Outcome Measure; Patient Care; Patients; Pattern; Penetration; Personal Satisfaction; Pharyngeal structure; Phase; Physiological; Physiology; Public Health Informatics; Quality of life; Randomized; Refractory; Rehabilitation therapy; Reporting; Reproducibility; Research; Resistance; Respiration; Risk; Science; Services; Site; Standardization; System; Testing; Texture; Toxic effect; Training; Translations; Veterans; active method; arm; cancer care; cancer therapy; care burden; care coordination; clinical application; clinical efficacy; clinical practice; clinical translation; clinically relevant; compliance behavior; cost; design; drinking; feasibility testing; functional improvement; functional outcomes; improved; innovation; intervention effect; mobile computing; novel; patient population; primary outcome; programs; prototype; recruit; rehabilitative care; respiratory; response; secondary endpoint; standard of care; tongue root; treatment arm

Despite important advancements in medical and surgical cancer treatments that prolong survival, veterans with oropharyngeal head and neck cancer (OP HNC) are faced with chronic, intractable dysphagia resulting in persistent drastic alterations in diet, the need for feeding tubes, and increased risk for aspiration pneumonia – a life threatening infection. We must devote research and clinical efforts to mitigate these devastating impairments because currently our rehabilitative intervention options are severely limited. As such, and in keeping with the VHA’s Blueprint for Excellence Transformative Actions, the need for the development of effective swallowing interventions that show potential for rapid translation to clinical practice is imperative. Respiratory-swallow coordination is an essential element of airway protection during swallowing and facilitates many key aspects of swallowing physiology. This key coordinative event is significantly disrupted in patients who are dysphagic following medical and surgical treatments for OP HNC. [Our preliminary trial tested an innovative swallowing treatment approach developed in our clinical laboratory, respiratory-swallow training (RST), that targets respiratory-swallow coordination directly and resulted in compelling improvements in physiologic swallowing outcomes in veterans suffering from dysphagia that persisted long after traditional behavioral swallowing intervention(s). The goal of this proposed trial is to extend our preliminary study using a rigorous, randomized cross over design and determine the impact and durability of RST on clinical outcomes essential for eating, drinking, health, and quality-of-life in veterans with OP HNC. As such, positive results from the proposed trial have high significance and clinical relevance for veterans’ health and well-being.] A total of 88 subjects will be recruited and randomly assigned 1:1 to either RST (intervention arm) or no active treatment (control arm), which is considered standard of care in this patient population. Data obtained will be used to evaluate clinical efficacy and durability. Data obtained from [an additional 11] subjects randomized to RST + home practice (HP) will be used to assess the feasibility of adjuvant HP program and to obtain preliminary data on its added impact on efficacy and response durability. The primary efficacy endpoint is Functional Oral Intake Scale level, and the secondary endpoint will be respiratory-swallow phase patterning. We will also elaborate on the impact of RST by detailing the physiological, airway protective, and morphometric changes that occur. We will use reproducible, reliable, and validated metrics that include the Modified Barium Swallow Impairment Profile, Penetration-Aspiration Scale, and Computational Analysis of Swallowing Mechanics to distinguish the mechanistic effects of RST. Further, adherence to a novel HP component using self-guided practice will be introduced and tested for feasibility and contribution to the degree and durability of the RST intervention effect. Our overarching goal is to provide two parallel tracks of knowledge generation: 1) provide immediate clinical translation of experimental findings to improve the lives of veterans, and 2) drive model generation on fundamental mechanisms of motor coordination. Basic knowledge will drive clinical application and vice-a- versa. As such, this is an ideal experimental and clinical context that will fuel knowledge generation in this highly significant area of science and clinical practice.

尽管在延长生存期的医学和外科癌症治疗方面取得了重要进展， 口咽头颈癌（OP HNC）面临慢性、顽固性吞咽困难， 饮食的持续剧烈改变，需要喂食管，以及吸入性肺炎的风险增加- 危及生命的感染我们必须致力于研究和临床努力，以减轻这些破坏性的 因为目前我们的康复干预选择非常有限。因此，在 与VHA的卓越转型行动蓝图保持一致，需要开发 显示出快速转化为临床实践潜力的有效吞咽干预是必要的。 呼吸-吞咽协调是吞咽过程中气道保护的基本要素， 吞咽生理学的许多关键方面。这一关键的协调事件在患者中被显著破坏 在OP HNC的内科和外科治疗后吞咽困难的患者。[Our初步试验测试了 在我们的临床实验室开发的创新吞咽治疗方法，吞咽训练 (RST)，直接针对自动吞咽协调，并在以下方面取得了令人信服的改善： 传统吞咽治疗后长期存在吞咽困难的退伍军人的生理吞咽结果 吞咽行为干预。这项拟议试验的目标是扩展我们的初步研究， 严格的随机交叉设计，并确定ESPRIT对临床结局的影响和持久性 对于患有OP HNC的退伍军人的饮食，健康和生活质量至关重要。因此，积极的结果， 拟议的试验对退伍军人的健康和福祉具有高度的意义和临床相关性。 将招募总共88名受试者，并以1：1的比例随机分配至研究组（干预组）或无活性药物组。 治疗（对照组），这被认为是该患者人群的标准治疗。获得的数据将 用于评价临床疗效和耐久性。从[另外11例]随机分配至 将使用辅助HP+家庭实践（HP）评估辅助HP计划的可行性，并获得 关于其对疗效和反应持久性的额外影响的初步数据。主要疗效终点是 功能性口服摄入量表水平，次要终点将是吞咽阶段模式。 我们还将通过详细描述生理、气道保护和形态测量来详细说明呼吸机的影响。 发生的变化。我们将使用可重现、可靠和经验证的指标，包括改良钡 吞咽损伤特征、渗透-误吸量表和吞咽的计算分析 力学，以区分机械的影响。此外，使用新的HP组件的粘附性 自我指导的做法将被引入和测试的可行性和贡献的程度和持久性， 干预效应。 我们的首要目标是提供两个平行的知识生成轨道：1）提供即时的临床 翻译实验结果，以改善退伍军人的生活，和2）驱动模型生成上 运动协调的基本机制。基础知识将推动临床应用， 亦然因此，这是一个理想的实验和临床背景，将推动知识的产生， 非常重要的科学和临床实践领域。