NCT01046929已完成1 期
Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- breast tissue limonene level
研究概览
简要总结
Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.
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
- •Women who are 18 years of age or older
- •Women electing to undergo excision surgery for early stage breast cancer
- •A minimum of 2 weeks from enrollment to definitive surgery
- •Underwent core needle biopsy for breast cancer diagnosis
- •No clinical evidence of metastatic breast cancer
- •ECOG performance status 0-1
- •Participants must have normal organ and marrow function
- •Women of child-bearing potential must agree to use adequate contraception
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Concurrent chemotherapy or radiation therapy
- •Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
- •History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
- •Participated in another clinical intervention trial within the past 3 months
- •Uncontrolled intercurrent 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
- •Pregnant or breast-feeding women
- •Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months
研究组 & 干预措施
limonene
Experimental
干预措施: limonene (Dietary Supplement)
结局指标
主要结局
breast tissue limonene level
时间窗: 2 - 6 weeks
次要结局
- drug effect biomarkers in the breast tissue and serum(2 - 6 weeks)
研究者
Sherry Chow
Research Professor of Medicine
University of Arizona
研究点 (2)
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