At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) with current oncogenic HPV positivity
- ✓Cervical dysplasia by colposcopy or positive biopsy
- ✓No invasive cervical cancer or high-grade intraepithelial neoplasia (CIN 2/3) on biopsy or endocervical curettage
- ✓Able and willing to attend clinic visits every 4 weeks for the duration of the study
- ✕History of allergic reaction to tea or related dietary products
- ✕HIV positive patients or AIDS/HIV-associated complex
- ✕Uncontrolled intercurrent illness including active infection (other than HPV), symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
- ✕History of any cancer except nonmelanoma skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Polyphenon E for Cervical Cancer Prevention
In Brief
A Phase 2 clinical trial evaluating placebo, defined green tea catechin extract, and 1 other intervention for Cervical Cancer and 2 related conditions. Completed, enrolled 98 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given orally
Given orally
Correlative studies