Respiratory Phase Training Effects on Swallow Impairment in Oropharyngeal Cancer

描述(申请人提供)：吞咽障碍(吞咽困难)是一种功能性疾病，影响大多数口咽癌患者的治疗。许多患者在接受癌症治疗后很长时间仍存在慢性吞咽困难，影响了他们的营养、健康和生活质量。最近的初步数据显示，在健康、正常人和口咽癌患者之间，呼吸-吞咽时相关系及其与吸入和吞咽困难的关系存在显著差异。这项I期临床试验的直接目标是测试一种新的呼吸-吞咽干预措施对口咽癌治疗后慢性吞咽障碍患者吞咽障碍和吸入的影响。在液体吞咽过程中出现“非最佳”呼吸-吞咽时相模式和可测量的吞咽损害的患者将学习到一种“最佳”生理模式，该模式在吞咽过程中同时具有呼吸道保护和机械优势。这项研究的主要目标是开发理想的呼吸吞咽阶段的训练方法和方案，单独或与传统的吞咽治疗相结合，改善吞咽功能，减少康复急性期的吸入。我们的目的是利用这些初步数据来推动一项更大规模的临床试验，如果有必要的话，并将该方法扩展到其他有呼吸吞咽相损伤迹象的患者组(例如肺部疾病和中风)。公共卫生相关性：这项临床试验的直接目标是测试一种新的呼吸-吞咽干预措施对接受口咽癌治疗的慢性吞咽障碍患者的吞咽障碍和吸入的影响。从这项探索性临床试验中获得的数据将被用于开发一项更大的临床试验，并将该方法扩展到其他有呼吸吞咽相损害迹象的患者组。

DESCRIPTION (provided by applicant): Swallowing impairment (dysphagia) is a functional morbidity that impacts the majority of patients treated for cancers of the oropharynx. Many patients remain chronically dysphagic long after their cancer treatments affecting their nutrition, health, and quality of life. Recent preliminary data have shown significant differences between healthy, normal individuals and patients treated for oropharyngeal cancers in respiratory-swallow phase relationships and their association with aspiration and dysphagia. The immediate goal of this phase I clinical trial is to test the effect of a novel respiratory-swallow intervention on swallowing impairment and aspiration in a cohort of chronically dysphagic patients following treatment for oropharyngeal cancer. Patients presenting with a "non-optimal" respiratory-swallow phase pattern during liquid swallows and measurable swallowing impairment will learn an "optimal" physiologic pattern that facilitates both airway protective and mechanical advantages during swallowing. The broad goal of this research is to develop ideal respiratory- swallowing phase training methods and regimens that alone or combined with traditional swallowing treatments improve the swallowing function and reduce aspiration in the acute phases of recovery. Our intention is to use these preliminary data to motivate a larger clinical trial, if warranted, and expand the approach to other patient groups that have indications of respiratory-swallow phase impairments (e.g. pulmonary disease and stroke). PUBLIC HEALTH RELEVANCE: The immediate goal of this clinical trial is to test the effect of a novel respiratory-swallow intervention on swallowing impairment and aspiration in a cohort of chronically dysphagic patients who have been treated for oropharyngeal cancer. Data obtained from this exploratory clinical trial will be used to develop a larger clinical trial and expand the approach to other patient groups that have indications of respiratory-swallow phase impairments.