Trial Information

Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"

Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to
control the disease are often devastating to the functional feeding outcome in these
patients. Most patients will experience some degree of dysphagia along with nutritional
decline. In particular, the swallowing outcome of those patients treated with external beam
radiation is suggested to be poorer than those patients treated by surgical interventions
alone. It has also been postulated that the formation of radiation-induced fibrotic tissue,
along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively
to promote muscular disuse or atrophy, and the noted decline in swallowing function. We
therefore suggest that a program of swallowing exercises may help facilitate and maintain
muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or
supporting swallowing function in these patients.

This study will follow a randomized controlled trial design. Patients with confirmed head /
neck cancer identified for planned radiotherapy will undergo a baseline evaluation including
clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to
CRT. Subjects will then be randomized to one of three intervention arms representing
control, placebo and intervention groups. Patients will be treated for 6 weeks and progress
reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary
outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue
composition over time as identified by T2 weighted MRI, II)Level of functional swallowing
ability,III)Patient perception of swallowing function and quality of life.The results of the
study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic
exercises for the maintenance of swallowing function post radiotherapy for Head /Neck
cancer.