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Gastro-esophageal Reflux | Evaluation of Esomeprazole in Treating Gastro-esophageal Reflux Disease (GERD) in Head and Neck Cancer Patients Exposed to Radiation Therapy

Gastro-esophageal Reflux research study

What is the primary objective of this study?

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 of cancer. Many people who have received head and neck radiation therapy develop a dry mouth as a result of the radiation damage to their saliva glands. In addition to the discomfort associated with a dry mouth, the decrease in saliva may increase the severity of gastro-esophageal reflux disease (acid reflux). Acid reflux occurs when acid escapes from your stomach into your throat. You may not have any symptoms of acid reflux, but often it can cause symptoms of heartburn or chest discomfort. Acid reflux can be treated once it is diagnosed. Treatment consists of dietary changes, behavioral alterations, and medication. Medications are available that decrease the amount of acid in your stomach. Diagnosis of acid reflux is made with a pH-probe to test for acid in your throat.

Who is eligible to participate?

Inclusion Criteria: 1. Signed informed consent 2. History of head and neck cancer 3. Radiation Therapy (external beam or IMRT) 1. Must have received equal or greater than 5000 cGy cumulative dose 2. Must have complaint of xerostomia 3. Greater than three month interval since radiation treatment Exclusion Criteria: 1. Subjects unable to tolerate pH-probe in past 2. Subjects currently on proton-pump inhibitor (PPI) or H-2 receptor antagonist therapy 3. Prior history of esophago-gastric surgery 4. Symptoms of gastrointestinal bleeding (melena, hematemesis) 5. Known hepatic cirrhosis or esophageal varices 6. Prior esophageal perforation 7. Pregnant, nursing or not likely to be using adequate contraceptive measures 8. Subjects not predicted to survive duration of study 9. Subjects with allergies or sensitivities to proton-pump inhibitors 10. Psychological, familial, sociological or geographical conditions which do not permit Study follow-up and compliance with study protocol 11. Subjects predicted to undergo surgery, chemotherapy or radiation therapy for head and neck cancer during the course of study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastro-esophageal Reflux

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Esomeprazole (Nexium)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Terminated

Start Date: November 2004

Completed Date: February 2008

Phase: N/A

Type: Interventional

Design:

Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Douglas K trask, MD. Ph.D.

Lead Sponsor: Douglas Trask

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00222079

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