Pharyngocise Dose Response Study

In an earlier pilot study, a regime of simple swallowing exercises was identified as useful
in maintaining oropharyngeal muscle characteristics as measured by T2 weighted Magnetic
Resonance Imaging (MRI) and produced a trend toward improved function for swallowing in
patients undergoing radiotherapy for head and neck cancer. The purpose of this current study
is to evaluate the dose response of two levels of swallowing exercise intensity on the
maintenance of muscle composition and function for swallowing in Head/Neck cancer patients
undergoing radiotherapy.

HYPOTHESIS: A program of intensive swallowing exercise (Pharyngocise) will maintain muscle
function in the oral cavity and pharynx during radiotherapy, preserving or supporting
swallowing function in Head/Neck cancer patients.

STUDY DESIGN: 130 patients with Head/Neck cancer, confirmed by clinical history and exam,
will be recruited over a 4 year period. All subjects will undergo an initial baseline work
up, including a standardized clinical and instrumental swallowing evaluation, psychosocial
scales, nutritional exam, and T2 weighted MRI prior to the first radiation therapy. Subjects
will be randomized into 1 of 3 groups:

Group A: Usual care (control) group - patients will receive swallowing and prescribed
dietary intervention during the radiotherapy period prescribed by the attending physician.

Group B: High intensity pharyngocise treatment group - patients will receive twice daily
swallowing intervention by a speech language pathologist, consisting of the battery of
isometric/isotonic exercises.

Group C: Low intensity pharyngocise treatment group - patients will receive a single
instructional exercise session on the isometric/isotonic exercises from a Speech Language
Pathologist and a practice tape to support home practice of the exercises.

All patients will be treated for approximately 6 weeks and followed for 3 months post
treatment. Baseline assessments will be repeated. In addition, daily treatment details,
patients perception of current swallowing ability and progress in therapy will be recorded
by the Speech Pathologist. Participants will be independently monitored throughout the
treatment period by researcher blind to the treatment group assigned, via weekly phone
interview sessions. Compliance with the treatment techniques, and the occurrence of any
negative endpoints such as occurrence of aspiration pneumonia will be recorded.