NCT03149081已完成1 期
A "Window Trial" on Boswellia, an Extract From Frankincense, for Breast Primary Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in tumor proliferation rate
研究概览
简要总结
The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.
详细描述
To determine whether oral administration of Boswellia serrata causes biological changes related to angiogenesis (CD31), apoptosis (DNA fragmentation), and cell proliferation (Ki67) in primary tumors of breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam
- •18 years of age or older
- •Subject must understand risks and benefits of the protocol and be able to give informed consent
- •Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result before and throughout the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic and end organ function
- •Ability and capacity to comply with the study and follow-up procedure
- •Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day
- •At least 6 sections of unstained slides should be obtained. If sufficient slides or tissue is unavailable, the patient will be excluded from the trial.
排除标准
- •Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- •Subjects with end-stage kidney disease and/or grade II liver dysfunction
- •Subject has active or history of deep vein thrombosis (DVT)
- •Subject has a history of coagulopathies or hematological disorders
- •Subjects who are pregnant or are lactating.
- •Subjects already taking drugs known to be 5-lipoxygenase inhibitors (Refer to section 5)
- •Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-Glycoprotein (P-Gp) (Refer to section 5.)
- •Subjects taking anti-coagulants or platelet inhibitors (Refer to section 5)
- •Subjects with bowel obstruction
- •Subjects undergoing emergency surgery.
研究组 & 干预措施
Boswellia
Experimental
Boswellia will be given at 800mg by mouth three times a day, immediately after each meal. Boswellia will be given from the time surgical resection is scheduled until the night before surgical resection.
干预措施: Boswellia (Drug)
结局指标
主要结局
Change in tumor proliferation rate
时间窗: up to 56 days
Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia
次要结局
- Number of adverse events reported(up to 84 days)
- Changes in tumors analyzed through immunohistochemistry(up to 56 days)
研究者
研究点 (1)
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