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 13, 2012
Last verified: July 2012
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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: defined green tea catechin extract 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 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 CIN2, 3, CIS 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 green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
|
Drug: defined green tea catechin extract
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 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
- 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 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.
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
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00303823 History of Changes |
| Other Study ID Numbers: | CDR0000458081, UARIZ-UAZ03-1-02, UARIZ-HSC-0540 |
| Study First Received: | March 15, 2006 |
| Results First Received: | July 13, 2012 |
| Last Updated: | July 13, 2012 |
| 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 Precancerous Conditions Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013