Clinical Trial: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)

Brief Summary: The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Detailed Summary: Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.
Sponsor: University of Chicago

Current Primary Outcome: Percent change in K167 staining [ Time Frame: Prior to starting study and after 4-6 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease in MRI volume and signal enhancement ratio (SER) of the breast lesion from pre- to post-treatment. [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of CD68 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of CD31 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of VEGF in breast tissue [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  • Change in serum levels of IGF-1 [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  • Safety of green tea ingestion [ Time Frame: Weekly for duration of study ]


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: January 29, 2010
Date Started: May 2010
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016