Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

Objectives:

Primary Objective:

Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6-12 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 6-12 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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: TAP Pharmaceutical Products Inc.
• Treatments: Dexlansoprazole; Lansoprazole

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)