Trial Information

Evaluation and Treatment of Reflux Disease in Patients With Head and Neck Cancer Undergoing Radiation Therapy That Causes Significant Mucositis in the Reflux Field and Xerostomia

The Study Drug:

Dexlansoprazole is designed to block the production of excess stomach acid that is the cause
of acid reflux disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2
groups, based on the results of your screening tests.

If you are assigned to Group 1, you will not receive any study drug, but you will complete
the study visits and radiation therapy, as described below.

If you are assigned to Group 2, you will receive Dexlansoprazole.

Study Drug Administration:

Dexlansoprazole is an dissolving tablet that is taken by mouth. It dissolves on the tongue.
It should not be swallowed whole with water like a regular pill. You will take 1 tablet,
once daily. The study drug should be taken first thing in the morning on an empty stomach,
and then you should not eat or drink anything but water for 30-45 minutes after taking the
study drug.

Study Visits:

Before you have the scheduled radiation therapy, you will have study visits. At these
visits, the following tests and procedures will be performed:

- You will have a pH-probe test performed.

- You will complete the PRO questionnaires.

- You will have a whole mouth salivary flow (WMSF) test. To perform this test, you will
chew a piece of non-flavored gum, and spit into a cup for after about 5 minutes. The
amount saliva will be weighed and recorded to compare it the amount recorded after
radiation therapy.

Radiation Therapy:

After you have completed the study visits, you will have the scheduled radiation therapy.
You will be asked to sign a separate consent form for this.

Length of Study:

You will remain on study from the beginning of radiation therapy until the 6-12 week follow
up visit is completed. After your participation on this study is over, you should speak
with your primary doctor about long term treatment. If your acid reflux disease gets worse
while on study, you will be recommended for a gastrointestinal (GI) evaluation and
treatment. If you experience intolerable side effects, you will be taken off study.

Follow-Up Visits:

About 6-12 weeks after you have completed radiation therapy, you will have a follow up
visit. At this visit, the following tests and procedures will be performed:

- You will have a pH-probe test performed.

- You will complete the PRO questionnaires.

This is an investigational study. Dexlansoprazole is FDA approved and commercially
available for the treatment of acid reflux disease.

Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.