A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
- Interventional
- Active
- NCT01060345
Contact Information
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
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.
Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.