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A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676793
First Posted: May 13, 2008
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Columbia University
Information provided by (Responsible Party):
Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
Results First Submitted: September 2, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Breast Cancer
Intervention: Drug: Polyphenon E

  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
ECGC and Breast Cancer Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.

Participant Flow:   Overall Study
    ECGC and Breast Cancer
STARTED   32 
COMPLETED   19 
NOT COMPLETED   13 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
ECGC and Breast Cancer Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.

Baseline Measures
   ECGC and Breast Cancer 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      30  93.8% 
>=65 years      2   6.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Serum VEGF in Breast Cancer   [ Time Frame: Baseline and 4 to 6 weeks ]

2.  Primary:   Change in Serum HGF and Breast Cancer   [ Time Frame: Baseline and 4 to 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Jerry w. McLarty, Ph.D.
Organization: LSU Health, Shreveport
phone: (318)813-1446
e-mail: jmclar@lsuhsc.edu


Publications of Results:
Proffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05


Responsible Party: Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676793     History of Changes
Other Study ID Numbers: H04-179
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: September 2, 2011
Results First Posted: October 26, 2012
Last Update Posted: September 21, 2017