Status:
TERMINATED
Evaluation of Esomeprazole in Treating Gastro-esophageal Reflux Disease (GERD) in Head and Neck Cancer Patients Exposed to Radiation Therapy
Lead Sponsor:
Douglas Trask
Conditions:
Gastro-esophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to measure acid reflux into the throat both before and after medical treatment in people who have had radiation therapy to their head and neck for the treatment o...
Detailed Description
The annual incidence of squamous cell carcinoma of the head and neck (SCCHN) is 40,000 cases per year in the US and 60,000 cases per year in Europe. Radiation therapy is employed in combination with c...
Eligibility Criteria
Inclusion
- Signed informed consent
- History of head and neck cancer
- Radiation Therapy (external beam or IMRT)
- Must have received equal or greater than 5000 cGy cumulative dose
- Must have complaint of xerostomia
- Greater than three month interval since radiation treatment
Exclusion
- Subjects unable to tolerate pH-probe in past
- Subjects currently on proton-pump inhibitor (PPI) or H-2 receptor antagonist therapy
- Prior history of esophago-gastric surgery
- Symptoms of gastrointestinal bleeding (melena, hematemesis)
- Known hepatic cirrhosis or esophageal varices
- Prior esophageal perforation
- Pregnant, nursing or not likely to be using adequate contraceptive measures
- Subjects not predicted to survive duration of study
- Subjects with allergies or sensitivities to proton-pump inhibitors
- Psychological, familial, sociological or geographical conditions which do not permit Study follow-up and compliance with study protocol
- Subjects predicted to undergo surgery, chemotherapy or radiation therapy for head and neck cancer during the course of study
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00222079
Start Date
November 1 2004
End Date
February 1 2008
Last Update
December 14 2017
Active Locations (1)
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1
University of Iowa Department of Otolaryngology
Iowa City, Iowa, United States, 52242