Comparison of Two Therapies for UES Dysphagia

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DESCRIPTION (provided by applicant): Pharyngeal phase dysphagia can be a severe and costly side effect of stroke and chemoradiation therapy for head and neck cancer, causing the patient to regularly aspirate and be unable to eat by mouth. A major subset of pharyngeal phase dysphagia is caused by inability to move the bolus completely through the upper esophageal sphincter (UES) during swallowing. Available therapy for this condition is limited and yields a degree of success, but a new therapy procedure, the Shaker exercise, offers an exciting new opportunity to rehabilitate these patients perhaps more effectively and efficiently than the usual therapy program. The 5 year project we are proposing is a randomized clinical trial of these two therapies in patients with severe pharyngeal phase dysphagia with inability to move the bolus completely through the UES. The patients must be non-oral for at least three months because of aspiration of residue from either or both the valleculae and pyriform sinuses. The primary objective of this project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for post chemoradiation therapy, head and neck cancer, and stroke patients. Our outcome measure is return to oral feeding, i.e., 100-percent of nutrition and hydration by mouth. Our secondary objectives are to: 1) determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100-percent oral intake, than patients with residue in the valleculae or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two studied groups of dysphagic patients, and 2) define the pathophysiological elements which change as a result of each therapy program including changes in a. anteroposterior and lateral diameter of maximum deglutitive UES opening, and b. maximum deglutitive laryngeal anterior and superior excursions.