Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00928161|
Recruitment Status : Withdrawn
First Posted : June 25, 2009
Last Update Posted : September 7, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oropharyngeal Cancer Gastroesophageal Reflux Disease||Drug: Dexlansoprazole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2014|
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.
- Frequency of acid reflux episode (during each 24 hour pH probe) [ Time Frame: Before radiotherapy and again at 6 weeks following radiotherapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928161
|Study Chair:||David I. Rosenthal, MD, MA, BA||UT MD Anderson Cancer Center|