Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Absolute Change in Mean Proliferative Rate Measured by Ki67%
研究概览
简要总结
The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.
详细描述
A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.
Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Female 18 + years of age
- •Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery
- •Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
- •Agree to avoid cruciferous vegetable/condiment intake for 14 days
- •Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes
排除标准
- •Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
- •Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
- •Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
- •Smoked within the past 12 months prior to eligibility screening;
- •Active infection or inflammation of the breast at time of eligibility screening
- •Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range
研究组 & 干预措施
Broccoli sprout extract
Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day.
干预措施: Broccoli sprout extract (Drug)
Broccoli sprout extract
Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day.
干预措施: Mango juice (Drug)
Mango juice
Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
干预措施: Mango juice (Drug)
结局指标
主要结局
Absolute Change in Mean Proliferative Rate Measured by Ki67%
时间窗: Change from baseline to 14 days post-intervention
Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.
次要结局
- Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor(Change from baseline to 14 days post-intervention)