Trial record 1 of 5 for:    cervical cancer and green tea
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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303823
First received: March 15, 2006
Last updated: July 9, 2013
Last verified: July 2012
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Drug: Polyphenon E
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: November 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral Polyphenon E once daily for 16 weeks in the absence of unacceptable toxicity.
Drug: Polyphenon E
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Assess the effect of Polyphenon E(defined green tea catechin extract) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting.

Secondary

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

Tertiary

  • 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 Polyphenon E once daily (standardized to contain 800 mg of epigallocatechin gallate, a major green tea catechin) 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.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303823

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Tucson, Arizona, United States, 85258
Sponsors and Collaborators
University of Arizona
Investigators
Study Chair: Francisco A. R. Garcia, MD, MPH University of Arizona
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303823     History of Changes
Other Study ID Numbers: NCI-2009-00893, UARIZ-UAZ03-1-02, UARIZ-HSC-0540, CDR0000458081
Study First Received: March 15, 2006
Results First Received: July 13, 2012
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
cervical cancer
cervical intraepithelial neoplasia grade 1
human papilloma virus infection

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ
Uterine Diseases
Genital Diseases, Female
Carcinoma

ClinicalTrials.gov processed this record on April 17, 2014