Effects Of Swallowing Therapy On Oropharyngeal Function In Head And Neck Cancer Patients

6046 Background: Head and neck cancer patients exhibit significant swallowing impairment after completion of tumor treatment. The most effective type of swallowing therapy for these patients has not been defined. Methods: This multi-center Phase III prospective randomized clinical trial tested which of two swallowing therapy protocols resulted in the best swallowing outcomes. The two therapy programs are: 1) aggressive range of motion (ROM) exercises with postural sensory therapy and 2) postural sensory therapy alone (PS). Planned enrollment was 99 patients per study arm. This sample size had 85% power to detect a difference in the primary outcome of 15% at a Type I error rate of 5%. Patients included those whose treatment was chemoradiation, supraglottic laryngectomy, anterior or posterior resection with primary or skin graft closure, anterior or posterior resection with distal or free flap closure. Both therapy protocols involved a one month treatment program followed by one month of rest followed by one month of exercise (ROM) or refresher (PS). Primary outcome measure was the percentage of patients with at least 50% oral intake at 3 months post cancer treatment. Other outcomes included physiologic measures determined from videofluorography at 6 visits between 1 and 12 months post cancer treatment completion. Results: Seventy-three patients were randomized (33 ROM, 40 PS). 58 patients were assessed at 3 months and 34 at 12 months. Fifty-five patients had chemoradiation while 18 had surgical treatment. There were no significant differences in the primary outcome measure (ROM 52%, PS 48%, p=0.99 by Fisher's exact test) or in other measures of swallow function. Conclusions: Neither swallowing therapy program was superior. No significant intervention-related adverse events were reported in either group. There were no significant differences between the treatment groups in the amount and types of foods eaten, saliva weight or mucositis. Frequency of some swallowing disorders decreased over time (e.g. reduced laryngeal elevation, reduced tongue strength) while others did not (e.g. reduced vertical tongue movement) indicating that both swallowing therapies may result in selective improvements in swallow physiology. No significant financial relationships to disclose.