Respiratory Phase Training Effects on Swallow Impairment in Oropharyngeal Cancer

描述（由申请方提供）：吞咽障碍（吞咽困难）是一种功能性疾病，影响大多数接受口咽癌治疗的患者。许多患者在癌症治疗后长期存在慢性吞咽困难，影响他们的营养、健康和生活质量。最近的初步数据显示，健康、正常个体和口咽癌治疗患者之间在吞咽-吞咽阶段关系及其与误吸和吞咽困难的相关性方面存在显著差异。这项I期临床试验的直接目标是测试一种新的吞咽干预对口咽癌治疗后慢性吞咽困难患者队列中吞咽障碍和误吸的影响。在液体吞咽期间呈现“非最佳”吞咽-吞咽阶段模式和可测量的吞咽损伤的患者将学习“最佳”生理模式，其在吞咽期间促进气道保护和机械优势。本研究的广泛目标是开发理想的呼吸-吞咽阶段训练方法和方案，其单独或与传统的吞咽治疗相结合，改善吞咽功能并减少恢复急性期的误吸。我们的目的是使用这些初步数据来推动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吞咽期障碍适应症的患者群体（例如肺部疾病和中风）。公共卫生相关性：本临床试验的直接目标是在一组接受过口咽癌治疗的慢性吞咽困难患者中测试新型吞咽干预对吞咽障碍和误吸的影响。从该探索性临床试验中获得的数据将用于开发更大规模的临床试验，并将该方法扩展至具有吞咽期障碍适应症的其他患者组。

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.