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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303823
First received: March 15, 2006
Last updated: April 23, 2014
Last verified: April 2013
Results First Received: July 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 1
Human Papilloma Virus Infection
Interventions: Drug: placebo
Dietary Supplement: defined green tea catechin extract
Other: laboratory biomarker analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Polyphenon E (Defined Green Tea Catechin Extract) Patients receive oral Polyphenon E daily for 16 weeks
Placebo Patients receive oral placebo once daily for 16 weeks

Participant Flow:   Overall Study
    Polyphenon E (Defined Green Tea Catechin Extract)     Placebo  
STARTED     50     48  
COMPLETED     35     38  
NOT COMPLETED     15     10  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Polyphenon E No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Polyphenon E     Placebo     Total  
Number of Participants  
[units: participants]
  50     48     98  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     50     48     98  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.48  ± 8.78     28.27  ± 8.05     28.28  ± 8.39  
Gender  
[units: participants]
     
Female     50     48     98  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     50     48     98  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease   [ Time Frame: 4 months ]

2.  Primary:   Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]

3.  Primary:   No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]

4.  Primary:   Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: H-H. Sherry Chow, Ph.D.
Organization: The University of Arizona
phone: 520-626-3358
e-mail: schow@azcc.arizona.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303823     History of Changes
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 23, 2014
Health Authority: United States: Food and Drug Administration