This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.
PRIMARY OBJECTIVES: I. Assess the effect of green tea extract (Polyphenon E®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting. SECONDARY OBJECTIVES: I. Compare the toxicity of green tea extract vs placebo among patients with CIN 1. TERTIARY OBJECTIVES: I. Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical chemoprevention studies. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral green tea extract (Polyphenon E®) once daily for 16 weeks in the absence of unacceptable toxicity. ARM II: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity. After completion of study treatment, patients are followed for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
98
Given orally
Given orally
Correlative studies
Arizona Cancer Center - Tucson
Tucson, Arizona, United States
Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Time frame: 4 months
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time frame: 4 months
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time frame: 4 months
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.