Protocol Number: 02-NR-0133
Patients 16 years of age and older who are receiving chemotherapy under a National Cancer Institute protocol may be eligible for this study. The study may be expanded to include patients at the National Naval Medical Center, the Lombardi Cancer Center at Georgetown University Medical Center, and the Johns Hopkins Oncology Center. Normal volunteers will also be enrolled. Patients will have the following tests and procedures: - Dental clinic visit before chemotherapy followed by stem cell or bone marrow transplantation. This visit will include: - Interview regarding current medications and use of alcohol and cigarettes - Rating of mouth and throat pain - Photographs of the inside of the mouth - Examination of the teeth and gums - Buccal brush biopsy - For this procedure, the inside of the cheek is brushed gently to collect cells, which will be examined for markers of inflammation. - Etanercept or placebo treatment. Patients will be randomly assigned to swish 4 teaspoons of an etanercept solution or placebo (look-alike solution with no active ingredient) in their mouths for 30 seconds and then spit it out four times a day. They will start using the mouthwash the day before chemotherapy begins and stop when any stomatitis that has developed has healed and there is no oral or throat pain, or, when they are discharged from the hospital-whichever comes first. - Treatment evaluations. Baseline (7 days before the stem cell or bone marrow transplant), 2 days before the transplant, at days 2, 5, 7, 9, 12, and 14 after the transplant, or at discharge from the hospital-whichever occurs first. Patients will be evaluated with: - Rating of mouth and throat pain - Photographs of the inside of the mouth and examination for stomatitis using a small light - Buccal biopsy - Blood sample collection, drawn through the central line during a regularly scheduled blood collection
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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