The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients

Study Type: Prospective Randomized Clinical Trial

Introduction:

Organ sparing treatment for advanced head and neck cancer can affect the swallowing
mechanism via fibrosis of the structures responsible for effective and efficient bolus
movement from the oral cavity and through the pharynx into the esophagus. This fibrosis may
result in significant impairment of bolus transport. Range of motion exercises for the
swallowing structures may decrease the fibrotic effects of the radiation treatment and
improve swallowing outcomes after treatment.

Intervention:

Patients who have been diagnosed with head and neck cancer and who will be receiving
radiation therapy either with or without chemotherapy as cancer treatment will be randomized
to one of two swallowing treatment protocols. The first protocol will include the initiation
of intensive swallowing exercises to begin at the start of the cancer treatment. The second
treatment protocol will include the standard of care which provides swallowing evaluation
and treatment once symptoms of swallowing dysfunction are experienced by the patient.
Patients will not be given a choice of swallowing protocol. Those patients randomized to the
intensive therapy protocol will be required to participate in weekly swallowing therapy
sessions either in person or over the phone and perform the learned swallowing exercises
three times a day. In addition, these patients will document their swallowing practice on a
daily basis. The same investigator will provide all the swallowing treatment assuring that
all patients get the same treatment approach.

All patients will fill out a questionnaire about their swallowing ability called the
Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N). This is a quick,
clinician rated instrument consisting of three subscales: normalcy of diet, public eating
and intelligibility of speech. This scale has been proven reliable across raters and
sensitive to functional differences across a broad spectrum of head and neck cancer
patients. This questionnaire will be completed at the start of the cancer treatment, at the
completion of the treatment and at 3, 6, 12 and 24 months after treatment. In addition, the
nature of the patient's oral intake will be documented by the investigator using the
Functional Oral Intake Scale (FOIS) which is a seven point scale of diet tolerance. This
will be performed at the same intervals as the PSS-H&N. Presence or absence of PEG feedings
will also be documented at these same times. These scales will then be used to compare the
swallowing outcomes of the patients in the two different treatment protocols.

Inclusion criteria:

- Patient diagnosed with head and neck cancer who will be receiving radiation therapy
either alone of with chemotherapy as their treatment modality.

Exclusion criteria:

- Patients with a history of neurologic disease

- Patients with previous head and neck cancer or surgical or radiation treatment to the
head and neck region

- Patients taking medication that might effect their swallowing function

- Patients with gastroenterologic dysfunction

- Patients who have previously undergone swallowing therapy

- Patients with cognitive impairments that limit their ability to follow and comply
with multi-step commands