BACKGROUND: A feasibility chemoprevention trial of green tea and oral leukoplakia has been conducted. The purpose is to demonstrate the success and pitfalls of conducting such a population-based trial within Indian rural villages. METHODS: Two dosages of green tea were utilized: 3.6 g per day and 5.4 g per day. Compliance was measured using tea package counts and by measuring the blood concentration of the active anticancer compound in green tea, (-)-epigallocatechin-3-gallate (EGCG). RESULTS: Following a 3-year planning period, 13 villages were visited, and 1,203 tobacco users were interviewed in order to identify 64 participants suitable for trial inclusion. Of the subsequently 28 consenting individuals entered, 23 remained on protocol for the entire 6-month duration. Overall compliance was excellent, with participants consuming approximately 80% of prescribed packets. CONCLUSIONS: These results provide a basis for continuing international collaborative efforts in conducting population-based chemoprevention trials against head and neck cancer.
RCT Entities:
BACKGROUND: A feasibility chemoprevention trial of green tea and oral leukoplakia has been conducted. The purpose is to demonstrate the success and pitfalls of conducting such a population-based trial within Indian rural villages. METHODS: Two dosages of green tea were utilized: 3.6 g per day and 5.4 g per day. Compliance was measured using tea package counts and by measuring the blood concentration of the active anticancer compound in green tea, (-)-epigallocatechin-3-gallate (EGCG). RESULTS: Following a 3-year planning period, 13 villages were visited, and 1,203 tobacco users were interviewed in order to identify 64 participants suitable for trial inclusion. Of the subsequently 28 consenting individuals entered, 23 remained on protocol for the entire 6-month duration. Overall compliance was excellent, with participants consuming approximately 80% of prescribed packets. CONCLUSIONS: These results provide a basis for continuing international collaborative efforts in conducting population-based chemoprevention trials against head and neck cancer.