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||Drug: placebo Dietary Supplement: defined green tea catechin extract Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase II Trial of Polyphenon E for Cervical Cancer Prevention|
- 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 ]
|Study Start Date:||September 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Dietary Supplement: defined green tea catechin extract
Other Name: Polyphenon EOther: laboratory biomarker analysis
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Other Name: PLCBOther: laboratory biomarker analysis
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.
I. Compare the toxicity of green tea extract vs placebo among patients with CIN 1.
I. Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical chemoprevention studies.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303823
|United States, Arizona|
|Arizona Cancer Center - Tucson|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Francisco Garcia||Arizona Cancer Center - Tucson|