A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in apoptosis (cleaved caspase 3)
研究概览
简要总结
This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.
II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).
III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal (no menstrual cycle in the past 12 months)
- •Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)
- •No neoadjuvant endocrine therapy or chemotherapy within 12 months
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Willing to avoid cruciferous vegetable intake during the study period (2 weeks)
- •Demonstrate the ability to swallow and retain oral medication
- •Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
- •Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
- •Intolerance to broccoli/ITC-BSE taste
- •Current ingestion of broccoli sprout extract, which may confound study results
- •Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
- •History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
- •Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade >3
研究组 & 干预措施
Arm I (broccoli sprout extract)
Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
干预措施: Broccoli Sprout Extract (Drug)
Arm I (broccoli sprout extract)
Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (broccoli sprout extract)
Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
干预措施: Pharmacological Study (Other)
Arm II (placebo)
Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
干预措施: Pharmacological Study (Other)
Arm II (placebo)
Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in apoptosis (cleaved caspase 3)
时间窗: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in estrogen receptor expression (ER alpha and ER beta)
时间窗: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in cell proliferation (Ki-67)
时间窗: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in NQO1 expression
时间窗: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
次要结局
未报告次要终点