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Green Tea Extract may be a promising cancer prevention agent for oral cancer in patients with a pre-malignant condition known as oral leukoplakia in their mouth according to researchers at The University of Texas M. D. Anderson Cancer Center.
The study may be the first to examine green tea as a chemo preventative agent in this high-risk patient population. The researchers found that more than half of the oral leukoplakia patients who took the extract had a clinical response.
The study was led by Vassiliki Papadimitrakopoulou M.D., professor at the M. D. Anderson Cancer prevention Center in the Department of Thoracic/Head and Neck Medical Oncology. He states "The extract's lack of toxicity is attractive - in prevention trials, it's very important to remember that these are otherwise healthy individuals and we need to ensure that agents studied produce no harm."
In the Phase II dose-finding study, 41 M. D. Anderson oral leukoplakia patients were randomized between August 2002 and March 2008 to receive either Green Tea Extract or placebo. Participants took the extract, an oral agent, for three months at one of three doses three times daily. To best assess biomarkers, participants also underwent a baseline and 12-week biopsy, an important component in the design of the study, the researchers say.
"Collecting oral tissue biopsies was essential in that it allowed us to learn that not only did the green tea extract appear to have benefit for some patients, but we pointed to anti-angiogenic effects as a potential mechanism of action," said Anne Tsao, M.D., assistant professor in the Department of Thoracic/Head and Neck Medical Oncology, and the study's first author. "While preliminary because our patient population was so small, this gives us direction for further study."
Of those taking green tea at the two highest doses, 58.8% had a clinical response, compared with 36.4% in the lowest extract dose and 18.2% in the placebo arm. At an extended follow-up with a mean of 27.5 months, 15 participants had developed oral cancer, with a median time to disease development of 46.4 months. Another important finding, say the researchers, was that that the extract was well tolerated. Side effects, including insomnia and nervousness, were mostly seen in the high-dose group but produced no significant toxicity.
"While these are encouraging findings, much more research must be done before we can conclude that green tea may prevent oral or any other type of cancer. It's also important to remind people that this trial enrolled very few participants who, at the highest dose levels took the equivalent of eight cups of green tea three times a day," said Papadimitrakopoulo. "We need to further understand if green tea offers longer-term prevention effects for patients." More than 35,720 are expected to be diagnosed with oral and/or pharynx cancer this year and the five year survival rate is less than 50%.