Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

PRIMARY OBJECTIVES:

1. 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:

1. Compare the toxicity of green tea extract vs placebo among patients with CIN 1.

TERTIARY OBJECTIVES:

1. 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.

Eligibility

Ages Eligible for Study:   18 Years and older

Genders Eligible for Study:   Female

Accepts Healthy Volunteers:   No

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

More Information

Garcia FA, Cornelison T, Nuño T, Greenspan DL, Byron JW, Hsu CH, Alberts DS, Chow HH. Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia. Gynecol Oncol. 2014 Feb;132(2):377-82. doi: 10.1016/j.ygyno.2013.12.034. Epub 2014 Jan 2.

Responsible Party: National Cancer Institute (NCI)

ClinicalTrials.gov Identifier: NCT00303823

Other Study ID Numbers: NCI-2009-00893  NCI-2009-00893  CDR0000458081  HSC 05-40  05-0144-01  UAZ03-1-02  P30CA023074  N01CN35158

Study First Received: March 15, 2006

Results First Received: July 13, 2012

Last Updated: April 14, 2015

Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms: