Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 1, Human Papilloma Virus Infection
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic human papillomavirus (HPV) positivity At increased risk for developing cervical cancer due to >= 1 of the following criteria (documented 6-12 months ago)*: Positive oncogenic HPV on DNA hybrid capture Low-grade squamous intraepithelial lesion cytology Histopathologically documented CIN 1 on cervical biopsy [Note: *Patients must now have current CIN 1 by histology or colposcopy AND HPV positivity] Cervical dysplasia by colposcopy OR positive biopsy No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical biopsy or endocervical curettage ECOG performance status < 2 Total bilirubin < 2 times upper limit of normal (ULN) AST < 2 times ULN ALT normal Creatinine < 2.0 mg/dL Able and willing to return to clinic for study visits once every 4 weeks for the duration of the study No history of allergic reaction to tea or related dietary products No HIV positive patients (or AIDS/HIV-associated complex) No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection other than HPV Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with study requirements No history of any cancer except nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No regular intake of 6 or more servings of tea per week within 1 month prior to study entry No treatment for genital condyloma within 30 days prior to study entry No prior pelvic irradiation No concurrent tea (green, black, or oolong) or tea-derived products No other concurrent investigational agents
Sites / Locations
- Arizona Cancer Center - Tucson
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I
Arm II
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.