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

NCT00222079 | Terminated

• 1 other identifier: 200308067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastro-esophageal Reflux

Interventions

Esomeprazole (Nexium) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Trask: lead

Study Sites (1)

University of Iowa Department of Otolaryngology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Douglas K trask, MD. Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

US (1)