Head and Neck Cancer Clinical Trial
Official title:
Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
Patient at increased risk for developing a new head and neck squamous cell carcinoma are
invited to take part in this study.
The investigators of this trial will attempt to study the effectiveness of Celecoxib in
preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.
Celecoxib is being studied in precancerous lesions of the head and neck in part because, it
has been shown to prevent the progression of another type of precancerous polyps (a type of
abnormal growth) in patients at high risk for colorectal cancer. There are, however, no
published studies yet looking at this drug in humans for the prevention of head and neck
cancers. The U.S. Food and Drug Administration has approved celecoxib for arthritis and the
prevention of polyps in patients with familial adenomatous polyposis (a type of precancerous
syndrome in some families that can lead to colon cancer).
This study is being done to find out several things:
- Is celecoxib, also known by the trade name Celebrex ®, effective in reducing the
expression of precancerous markers (biological signals for specific cellular activities)
in oral leukoplakia and dysplasia (abnormal growth) of the oral mucosa?
- Is celecoxib effective in reducing the size of oral leukoplalda lesions and/or presence
of dysplasia?
- Does the reduction in precancerous markers correspond with reduction of oral leukoplalda
and/or presence of dysplasia?
- What are the side effects of celecoxib in this patient population?
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