A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Change in K167 Staining
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Women with Ductal Carcinoma in Situ
Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
干预措施: Polyphenon E (Drug)
结局指标
主要结局
Percent Change in K167 Staining
时间窗: Prior to starting study and after 4-6 weeks of treatment
次要结局
- Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.(Prior to study start and 4-6 weeks after treatment)
- Change in Percent Staining of CD68 in Breast Tissue(Prior to study start and 4-6 weeks after treatment)
- Change in Percent Staining of CD31 in Breast Tissue(Prior to study start and 4-6 weeks after treatment)
- Change in Percent Staining of VEGF in Breast Tissue(Prior to study start and after 4-6 weeks of treatment)
- Change in Serum Levels of IGF-1(Prior to study start and after 4-6 weeks of treatment)
- Safety of Green Tea Ingestion(6 weeks)