Are You an Oral Cancer Survivor with Frequent Dry-mouth?

One side effect of radiation is damage to cells in the salivary glands. This damage reduces the amount of saliva in the mouth, which 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 an Aquaporin 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 salivary cells, the gene is combined with a common cold virus. The Adenovirus 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 1 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.

You may be eligible to participate in this study (NIH Protocol 06-D-0206). There is no cost for participation or any tests associated with this research. The study is recruiting participants who are:
-Adults ages 18 and older
-Previously diagnosed with a cancer of the head and neck
-Experiencing dry mouth caused by radiation therapy
-Cancer-free (5 or more years)
-Not pregnant or breast feeding
-Current Non-smoker

To learn more about the study contact Linda McCullagh, RN, MPH, and include that you were referred by The Oral Cancer Foundation. She can be reached at [email protected]. More information may be found at ClinicalTrials.gov and www.drymouthstudy.com .

*Please include in your email that you were referred by the Oral Cancer Foundation. Thank you

I would just like to add to this that if you do not live near Bethesda, MD where the study will be conducted, your travel expenses WILL be covered. (As long as you live in the United States). Here are the details:

Please let anyone interested know that we do provide transportation (within the USA), accommodations and a daily meal allowance ($64.00/day) for participants. We've had people fly in from South Carolina, Florida, Arizona, Idaho, Michigan, Ohio, and soon, Minnesota, Toronto and New Mexico. Participants usually stay at the Safra Family Lodge on the NIH campus. During times of frequent visits (around the gene infusion) we invite those traveling from a distance to stay at the Lodge between visits. Family can travel ( at their own expense) and stay with the participant. The NIH is a subway ride from Washington DC.

We recognize that traveling to NIH to enroll in a clinical trial creates additional stress on participants. Our small team has over 100 years of combined experience in working with clinical trial participants (yes, some of us are old) and we attempt to buffer these stressors. Research volunteers are amazing people. We want them to know and feel that during their participation.

A resource for those asking about NIH and study participation is found at the Clinical Center website www.cc.nih.gov<http://www.cc.nih.gov/> . Information about Safra Family Lodge, research participation, Phase I studies, shuttle schedules, maps, and directions to NIH are found through this site. The study website offers general information at www.drymouthstudy.com<http://www.drymouthstudy.com/> . More detailed information about this trial is found through the recent article in Oral Oncology, attached.

I am always available to speak directly with anyone interested in this study. Please feel free to provide my email [email protected]<mailto:[email protected]> and cell 301-943-4315 or forward this email.

Thanks.
Linda