Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
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.
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).
- To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
- 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.
- 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.
- 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)
- Compare findings from the patient reported outcome (PRO) instruments used
Head and Neck Cancer
Gastroesophageal Reflux Disease
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Frequency of acid reflux episode (during each 24 hour pH probe) [ Time Frame: Before radiotherapy and again at 6 weeks following radiotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
No Intervention: Group 1
Patients with no acid reflux.
Active Comparator: Group 2
Patients with acid reflux.
Dissolving tablet taken by mouth (60 mg tablet), once a day. Take dose first thing in morning on empty stomach, then nothing but water for 30-45 minutes afterwards.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00928161
|Study Chair:||David I. Rosenthal, MD, MA, BA||UT MD Anderson Cancer Center|