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Cervical Cancer:
Phase 1b Study of Polyphenon E for Cervical Cancer Prevention

Who is conducting the study? This National Cancer Institute-funded study will be conducted by Arizona Cancer Center researchers at the University of Arizona.
Principal Investigator: Francisco Garcia, MD, MPH

What is the purpose of the Study?  The purpose of this randomized, placebo-controlled study is to evaluate the effect of Polyphenon E (a defined green tea extract) on persistent precancerous cells of the cervix.

How long is the study? To participate, patients are asked to devote a 6 month time period to the study.

Who is eligible for the study? 

Participants must meet the following criteria for inclusion:

• Age 18 or older
• Persistent mild dysplasia (precancerous cells of the cervix) 6-12 months prior to enrollment

Participants will be excluded for the following criteria:

• Treatment for genital condyloma within 30 days prior to screening
• HIV positive
• Prior pelvic irradiation
• Prior malignancy other than non-melanoma skin cancer
• Pregnant, nursing, or inadequate contraceptive measures
• Tea drinkers who have consumed more than 6 cups of green tea prior to enrollment

What is required during the study?

• Blood test to determine normal liver and kidney function
• Cannot be pregnant, and must be willing to use an effective contraception for the duration of the study
• 6 clinic visits – willing to come to the clinic every month for 4 months
• Take 4 study capsules every morning for 16 weeks
• Keep a study diary for 18 weeks
• Avoid any tea or tea products for the duration of the study

What to expect at your visit:

• Urine
• Pregnancy testing
• Pap smear
• Colposcopy
• Possible cervical biopsy
• Digital photography of the cervix
• Cervical specimens for HPV testing
• Blood draw

For more information, please contact:

Bonita Weible
(520) 318-7178

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