NCT00303823

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 17, 2012

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2013

Enrollment Period

5.2 years

First QC Date

March 15, 2006

Results QC Date

July 13, 2012

Last Update Submit

April 14, 2015

Conditions

Cervical CancerCervical Intraepithelial Neoplasia Grade 1Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (4)

  • Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease

    4 months

  • Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia

    4 months

  • No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia

    4 months

  • Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer

    4 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.

Dietary Supplement: defined green tea catechin extractOther: laboratory biomarker analysis

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.

Drug: placeboOther: laboratory biomarker analysis

Interventions

placeboDRUG

Given orally

Also known as: PLCB
Arm II
defined green tea catechin extractDIETARY_SUPPLEMENT

Given orally

Also known as: Polyphenon E
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center - Tucson

Tucson, Arizona, 85724-5024, United States

Location

Related Publications (1)

  • Garcia FA, Cornelison T, Nuno 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.

    PMID: 24388920DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPapillomavirus Infections

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
H-H. Sherry Chow, Ph.D.
Organization
The University of Arizona
schow@azcc.arizona.edu
520-626-3358

Study Officials

  • Francisco Garcia

    Arizona Cancer Center - Tucson

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

September 1, 2005

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

May 5, 2015

Results First Posted

August 17, 2012

Record last verified: 2013-04

Locations

US(1)