Phase 2 N=98 Randomized Double-blind Prevention

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

Bottom Line

View on ClinicalTrials.gov: NCT00303823 ↗

Enrolled (actual)

Serious AEs

1.0%

Results posted

Aug 2012

Primary outcome: Primary: Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease — 7; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: placebo (Drug); defined green tea catechin extract (Dietary_supplement); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: National Cancer Institute (NCI)
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease	7; 6	—
PRIMARY Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia	1; 6	—
PRIMARY No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia	27; 26	—
PRIMARY Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer	6; 3	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00303823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.