About the Study

Every year about 35,000 people in the United States are diagnosed with mouth and throat cancer. Many will be treated with radiation and surgery. One side effect of radiation is damage to the cells in the salivary glands. This damage to the cells reduces the amount of saliva in the mouth. The lack of saliva can cause problems such as dry mouth (xerostomia), difficulty swallowing, tooth decay, and yeast infections (thrush).

There is no cure for salivary gland damage caused by radiation. Dry mouth caused by radiation is often treated with artificial saliva or medicines that increase saliva flow. However, most treatments for dry mouth only treat the symptoms and bring temporary relief. They do not reverse the damage to the salivary glands.

Researchers at the National Institute of Dental and Craniofacial Research are investigating a new treatment for dry mouth. This treatment involves the insertion of a gene into the remaining cells of the salivary gland. This gene makes a protein that carries water across cells. To get the gene into the cells of the salivary gland, the gene is combined with a common cold virus. The cold virus is modified so that it will not cause infection in the body. The virus and gene are injected into one of the salivary glands. Research in animals has shown that this treatment can increase saliva flow for a short period of time with very few side effects.

The overall purpose of this research study is to learn more about the safety of this treatment in humans. A second purpose is to determine if the treatment can increase salivary flow and improve dry mouth. We expect that any improvements in dry mouth will only last a few days to two weeks. If this treatment increases salivary flow, it may be possible to develop a longer lasting treatment.

The study takes one year to complete and requires ten inpatient visits to the National Institutes of Health Clinical Center in Bethesda, MD. These visits typically last 2 to 4 days. The first two visits will help the study team decide whether you are eligible. The investigational treatment is given one time on the third visit. The other seven visits will help the study team learn more about the treatment.

More information about this study may be found at ClinicalTrials.gov.