Clinical Trial to Study Effects of Green Tea Extract on Cervical Cancer Prevention

The study will determine whether a green tea extract affects cancer-related biomarkers in blood and/or cervical tissue in women who test positive for human papillomavirus.

The Arizona Cancer Center is currently conducting a clinical investigation on the effects of Polyphenon E, a green tea extract, on cervical cancer prevention.

The study will determine whether Polyphenon E affects cancer-related biomarkers in blood and/or cervical tissue in women with persistent cervical dysplasia, CIN1, or low-grade squamous intra-epithelias lesions, or LSIL, or who test positive for oncogenic human papillomavirus, HPV. These are various types of cervical infections.

Tea (Camellia sinensis) is one of the world's most consumed beverages. Polyphenon E is a chemically defined, decaffeinated, catechin-enriched green tea extract.

Catechins are plant chemicals that are considered powerful antioxidants and have multiple beneficial biological effects that could lead to cancer prevention.

Approximately 20 million Americans are currently infected with HPV, and another 6.2 million become newly infected each year. Some types of HPV can cause cervical cancer.

The American Cancer Society estimates that there will be about 11,070 women diagnosed with cervical cancer in the United States in 2008. Rigorous clinical investigations are needed to determine whether green tea extracts such as Polyphenon E are effective reducing or preventing cervical cancer.

The study will recruit women who have had a diagnosis of persistent CIN1/HPV/LSIL for at least 6 to 12 months. Eligible participants will take either 800 mg. capsules of Polyphenon E (green tea extract) or a matched placebo for four months.

Monthly clinic visits will include a review of compliance and any side effects, and blood testing for liver function. The final clinic evaluation will additionally include a directed biopsy of the cervix and cervical curettage (a tissue sample of the cervix). All qualified participants will be compensated for their role in this study.

This study is sponsored by the National Cancer Institute's Division of Cancer Prevention. The principal investigators are Dr. Francisco Garcia, professor of obstetrics and gynecology at The University of Arizona College of Medicine and a member of the Arizona Cancer Center, and Dr. David Greenspan, a specialist in anatomic pathology and obstetrics and gynecology for the Maricopa Integrated Health System.

The Arizona Cancer Center is the state's premier National Cancer Institute-designated comprehensive cancer center. With primary locations a The University of Arizona in Tucson and in Scottsdale, the center has more than a dozen research and education offices throughout the state and 300 physician and scientist members working to prevent and cure cancer.