Clinical trial NCT01060345: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
Official title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ductal Carcinoma in Situ
Keywords: DCIS
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
* Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
* Age \>18 years.
* ECOG performance status \<2 (Karnofsky \>60%)
* Life expectancy of greater than 12 months.
* Normal organ and marrow function as defined below:
* leukocytes \>3,000/mcL
* absolute neutrophil count \>1,500/mcL
* platelets \>100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT) \& ALT(SGPT)within normal institutional limits
* creatinine \<1.5 times institutional upper limit of normal or creatinine clearance \>60 mL/min/1.73 m2
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnancy
* Patients who have undergone prior excisional biopsy for DCIS.
* Patients who are unable to undergo MRI due to claustrophobia or other reason.
* Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
* Patients receiving any other chemotherapy or investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
* Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Percent Change in K167 Staining
timeFrame: Prior to starting study and after 4-6 weeks of treatment
Secondary outcomes:
measure: Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
timeFrame: Prior to study start and 4-6 weeks after treatment
measure: Change in Percent Staining of CD68 in Breast Tissue
timeFrame: Prior to study start and 4-6 weeks after treatment
measure: Change in Percent Staining of CD31 in Breast Tissue
timeFrame: Prior to study start and 4-6 weeks after treatment
measure: Change in Percent Staining of VEGF in Breast Tissue
timeFrame: Prior to study start and after 4-6 weeks of treatment
measure: Change in Serum Levels of IGF-1
timeFrame: Prior to study start and after 4-6 weeks of treatment
measure: Safety of Green Tea Ingestion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Nora Jaskowiak, MD
role: PRINCIPAL_INVESTIGATOR
References: