A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
Since oral leukoplakia may precede the development of cancer, using agents that may prevent
cancer, called chemoprevention, may be useful. The purpose of this study is to determine
whether taking a green tea preparation may have effects on your leukoplakia. It is hoped
that these effects may reduce the subsequent risk of cancer in or around the area of
leukoplakia. To assess for these effects, samples of the lining of your mouth will be
obtained, and they will be analyzed looking for certain features (biomarkers).
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia.
Susan Goodin, PharmD
University of Medicine and Dentistry New Jersey
United States: Institutional Review Board
|The Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|