Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

If participant agrees to take part in this study, participant will complete the below study
tests at participant's first study visit and about 6 months after participant's radiation
treatment.

Questionnaire:

Participant will complete a questionnaire (either in the clinic or at home) about how well
participant is following the swallowing exercises and how participant has been coping with
stress. The questionnaire will also collect information about the disease and personal
information about participant, such as participant's age, sex, race, education level, and
marital status. This questionnaire should take about 30 minutes to complete. On the Day 1
visit, participant will not complete the part of the questionnaire that asks about
participant's swallowing exercises.

If participant prefers to complete the questionnaire online, a separate email will be sent to
participant's email address. The email will contain a link to a secure online questionnaire
protected by MD Anderson.

Cytokine Blood Tests:

Blood (about 1-2 teaspoons each time) will be drawn to measure the level of cytokines in
participant's blood 2 times. These blood samples will be drawn at the same time as other
routine blood draws so participant will not have extra needle sticks.

Researchers want to learn 1) if cytokine levels are related to changes in the types of side
effects participant may have, such as fatigue and nausea, 2) which patients are at risk for
developing permanent swallowing dysfunction after radiation treatment, and 3) which patients
are at risk for developing recurrence after treatment.

Researchers will also study participant's genetic code to try to predict cytokine levels or
what side effects participant may have. This means researchers may need to store parts of
participant's blood for a long time, maybe with no time limit, to complete the genetic
testing. However, these samples will only be used for research testing as described in this
consent form.

Length of Study:

Participant's active participation in this study will be over after participant completes the
6 month questionnaire and blood draw.

Information from participant's medical record (such as information about participant's
disease history, if the disease has gotten worse, any treatment participant receives, and any
side effects participant has) will continue to be collected for up to 2 years after
participant completes radiation therapy.

This is an investigational study.

Up to 230 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Are dispositioned to receive radiation with curative intent for nasopharyngeal,
oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical
metastases.

2. Are stage II-IVB for non- HPV- related oropharyngeal cancer

3. Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant
metastasis or have HPV- related oropharynx cancer that is at least T2 with with no
distant metastasis

4. Are stage II-IVb for laryngeal cancer

5. Are stage I-IVB for hypopharyngeal

6. Are stage I-IV for nasopharyngeal cancer

7. Have stage I-III unknown primary cancer with cervical

8. At least 18 years of age

Exclusion Criteria:

1. Have other cancer diagnoses, except non-melanoma skin cancer

2. Had treatment for previous head and neck cancer or radiation to the head and neck

3. Have a history of previous head and neck surgery (excluding biopsy and/or
tonsillectomy and/or tracheotomy)

4. Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia
due to underlying neurogenic disorder)