Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy

Study Visits:

If you are found to be eligible and you agree to take part in the therapeutic portion of the
EMST therapy study, you will be trained how to use the EMST device. This device is designed
to help strengthen the muscles used for swallowing and coughing. To use this small handheld
device, you will wear a nose clip to prevent air from coming out of your nose. You will be
asked to sit upright and take a deep breath, hold your breath for a moment, and then blow
forcefully into the device until you break the seal.

You will use the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per
week) for 8 weeks. Using the EMST device should take about 15 minutes each day you train.

One (1) time each week during these 8 weeks, you will meet with a speech pathologist in the
Head and Neck Center at MD Anderson. At each visit, you will use the digital manometer to
re-test how forcefully you are able to exhale and cough. The resistance of the EMST device
will be adjusted based on each week's measurement.

Length of Study:

You will be on study for up to 12 months. Your study participation will be over after the
follow-up call, described below. You will be taken off study early if you are unable to use
the EMST device, if the doctor thinks it is in your best interest, or if you are unable to
follow study directions.

Follow-Up Visit:

After 8 weeks of using the EMST device, you will have a follow-up visit.

- You will have the same functional testing you had at screening (the modified barium
swallow and tests of your tongue strength, mouth opening, and ability to exhale and
cough forcefully).

- You will complete the questionnaires and will be asked about your symptoms and quality
of life.

Follow-Up Call:

You will be contacted by phone 12 months after you joined the study to complete 4
questionnaires about your symptoms, health and quality of life. This call should take up to
15 minutes.

This is an investigational study. The EMST device is FDA approved for exercising the muscles
used in coughing and swallowing. Its use in preventing aspiration in patients who have
received radiation for head and neck cancer is considered investigational.

Up to 300 patients will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Age >/= 18 years

2. History of curative-intent radiotherapy at MDACC for a new primary H&N cancer in past
15 years

3. Referred to Section of Speech Pathology and Audiology for swallowing evaluation

4. Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

1. History of recurrent or second primary H&N, central nervous system, or thoracic cancer
at time of modified barium swallow (MBS) study

2. Prior H&N surgery excluding diagnostic procedures, transoral surgery, or non-radical
neck dissection

3. History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular
disease

4. Tracheotomy or oxygen dependence at time of MBS

5. Patients with Mini-Mental State Examination (MMSE) <24 will be ineligible for
participation in the therapeutic trial