Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

Condition(s) targeted: Head and Neck Cancer; Oropharyngeal Cancer; Gastroesophageal Reflux Disease

Intervention: Lansoprazole (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
David I. Rosenthal, MD, MA, BA, Study Chair, Affiliation: UT MD Anderson Cancer Center

Overall contact:
David I. Rosenthal, MD, MA, BA, Phone: 713-563-2300

The goal of this clinical research study is to learn if radiation-induced xerostomia [RIX] (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like symptoms) in head and neck cancer (HNC) patients receiving radiation therapy.

Primary Objective:

Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6 weeks after RT (measured by # episodes, their duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the curve for all episodes of pH<4 recorded during the study in units of Ph*minutes. The Reflux area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).

Secondary Objectives:

1. To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms

2. Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to determine if radiation induced hyposalivation is associated with more reflux events and symptoms.

3. For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion to acid-positive reflux measured approximately 6 weeks after RT.

4. Correlate office indirect laryngoscopy findings (posterior commissure thickening, cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)

5. Compare findings from the patient reported outcome (PRO) instruments used

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: Frequency of acid reflux episode (during each 24 hour pH probe)

Detailed description: The Study Drug:

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

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- You will complete patient reported outcome (PRO) forms, which consist of a total of 4

questionnaires. These questionnaires will ask questions about symptoms that you may have and will take about 5 minutes each to complete.

- You will have a pH-probe test performed. To perform this test, a small, soft plastic

tube with a sensor device on the end will be inserted through the nose and down the back of the throat into the esophagus, just above the stomach. Your nose will be numbed for this procedure, and the probe will be left in place for up to 24 hours. The sensor on the end of the tube measures the amount and frequency of acid reflux. This procedure will be performed by a speech language pathologist.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Drug Administration:

Lansoprazole 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, 2 times daily. The first dose of 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. The second dose of study drug should be about 12 hours after the first dose, again with nothing to eat or drink except water for at least 1 hour before and 30-45 minutes after.

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 6-8 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 6-8 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. Lansoprazole 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Signed informed consent.

2. Head and neck cancer (HNC) Oropharynx cancer (OPC) patients who are adults > 18 years of age, dispositioned to receive curative RT with bilateral neck (including) parotid irradiation with or without chemotherapy.

3. Radiation Therapy (3D conformal or IMRT).

Exclusion Criteria:

1. Subjects unable to tolerate pH-probe in past.

2. Subjects currently on proton-pump inhibitor (PPI), daily antacids and daily H2 antagonists.

3. Prior history of esophago-gastric surgery.

4. Symptoms of active gastrointestinal bleeding (melena, hematemesis).

5. Known hepatic cirrhosis or esophageal varices.

6. Prior esophageal perforation.

7. Pregnant or lactating woman. Women of childbearing potential who have not undergone a hysterectomy with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable and appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

8. Subjects with allergies or sensitivities to proton-pump inhibitors.

9. Patients who cannot complete study follow-up and compliance with study protocol.

10. Patients on Plavix (if medically appropriate)

David I. Rosenthal, MD, MA, BA, Phone: 713-563-2300

UT MD Anderson Cancer Center, Houston, Texas 77030, United States

UT MD Anderson Cancer Center website

Starting date: July 2009
Last updated: June 24, 2009