Terminated

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID00222079

Pilot Study to Evaluate Esomeprazole (Nexium) in Treating Gastro-esophageal Reflux in Patients With Head and Neck Cancer With Prior External Beam Radiation Therapy: a Randomized, Prospective, Placebo-controlled, Double-blind Study.

Led by Douglas Trask · Updated on 2017-12-14

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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

Trial Site Locations

Total: 1 location

1

University of Iowa Department of Otolaryngology

Iowa City, Iowa, United States, 52242

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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