Clinical trial to study effects of green tea extract on cervical cancer prevention

Clinical trial to study effects of green tea extract on cervical cancer prevention

FOR IMMEDIATE RELEASE: February 23, 2009
Contact: Ilya Sloan (520) 626-6401

TUCSON, Ariz. – 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 CIN1 or LSIL, or who test positive for oncogenic HPV (Human papillomavirus). 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 6-12 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 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 Francisco Garcia, MD, professor of obstetrics and gynecology at the University of Arizona College of Medicine and Arizona Cancer Center member, and David Greenspan, MD, a specialist in anatomic pathology and obstetrics and gynecology, Maricopa Integrated Health System.

For additional study-related information, please contact:
• Tucson: Dr. Garcia at (520) 626-8539 or Bonnie Weible at (520) 318-7178.
• Maricopa County: Blanca Flor Jimenez at (602) 344-5439.
• Scottsdale: Wendy Thomas at (480) 355-8127.