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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 13, 2012
Last verified: July 2012
History of Changes
Results First Received: July 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Precancerous Condition
Interventions: Drug: defined green tea catechin extract
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Polyphenon E No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Polyphenon E     Placebo  
STARTED     50     48  
COMPLETED     35     38  
NOT COMPLETED     15     10  



  Baseline Characteristics
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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
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1.  Primary:   Complete Response - Clearance of Oncogenic HPV and Complete Colposcopic, Histologic and Cytologic Clearance of Disease   [ Time Frame: 4 months ]
  Show Outcome Measure 1

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

3.  Primary:   No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]
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4.  Primary:   Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to CIN2, 3, CIS or Invasive Cancer   [ Time Frame: 4 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
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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


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