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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
The University of Chicago
Chicago, Illinois, United States
Percent Change in K167 Staining
Time frame: Prior to starting study and after 4-6 weeks of treatment
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
Number of patients with adverse event.
Time frame: 6 weeks
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