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: 10084171
• 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 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10084171
• 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.

尽管在内科和外科癌症治疗方面取得了重要进展，延长了生存期，但患有 口咽头颈部癌(OP HNC)面临慢性、顽固性吞咽困难，导致 饮食的持续剧烈变化，需要喂养管，以及吸入性肺炎风险的增加- 一种危及生命的感染。我们必须致力于研究和临床努力，以减轻这些毁灭性的影响 残疾，因为目前我们的康复干预选择严重有限。因此，在 符合VHA的卓越蓝图转型行动，发展的需要 有效的吞咽干预措施显示出快速转化为临床实践的潜力，这是当务之急。 呼吸-吞咽协调是吞咽过程中保护呼吸道的基本要素，并有助于 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受到严重干扰 在接受内科和外科治疗后出现吞咽困难。[我们的初步试验测试了一个 我们的临床实验室开发了创新的吞咽治疗方法，呼吸-吞咽训练 (RST)，它直接针对呼吸-吞咽协调，并导致显著改善 长期患有传统吞咽困难的退伍军人的生理性吞咽结果 行为吞咽干预(S)。这项拟议的试验的目标是使用一种 严格的随机交叉设计，并确定RST对临床结果的影响和持久性 对患有OP HNC的退伍军人的饮食、健康和生活质量至关重要。因此，积极的结果来自于 拟议的试验对退伍军人的健康和福祉具有很高的意义和临床意义。] 总共88名受试者将被招募，并被随机分配到RST(干预组)或不活动组 治疗(控制组)，这被认为是该患者群体的标准护理。获得的数据将是 用于评价临床疗效和耐受性。从[另外11个]受试者中随机获得的数据 将使用RST+家庭实践(HP)来评估HP佐剂计划的可行性，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。主要疗效终点为 功能性口腔摄入量水平，次要终点将是呼吸-吞咽相图案。 我们还将通过详细阐述RST的生理、呼吸道保护和形态测量来阐述RST的影响 发生的变化。我们将使用可重现的、可靠的和经过验证的指标，其中包括修改后的BAX 吞咽损害轮廓、穿透-吸入度及吞咽的计算分析 力学，以区分RST的机械效应。此外，使用 将引入并测试自我指导实践的可行性和对程度和持久性的贡献 RST干预效应。 我们的首要目标是提供两条平行的知识生成轨道：1)提供即时的临床 转化实验结果以改善退伍军人的生活，以及2)推动模型生成 运动协调的基本机制。基础知识将推动临床应用和副 反过来说。因此，这是一个理想的实验和临床环境，将推动知识的产生 非常重要的科学和临床实践领域。