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


N/A
18 Years
N/A
Open (Enrolling)
Both
Dysphagia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).

Outcome Description:

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. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) 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.

Outcome Time Frame:

This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.

Safety Issue:

No

Principal Investigator

Tamar Kotz, MS, CCC, SLP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

GCO # 07-0462

NCT ID:

NCT01349309

Start Date:

June 2007

Completion Date:

June 2012

Related Keywords:

  • Dysphagia
  • Prophylactic Swallowing Exercises
  • Head and Neck Cancer
  • Dysphagia
  • Deglutition Disorders
  • Head and Neck Neoplasms

Name

Location

Mount Sinai School of MedicineNew York, New York  10029