NCT01459172已完成1 期
Human Breast Tissue Bioavailability of Topically Applied Limonene
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- breast tissue bioavailability
研究概览
简要总结
The overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are 18-65 years of age
- •ECOG performance status 0-1
- •Normal organ and marrow function
- •Women of child-bearing potential must agree to use adequate contraception
- •Willing to avoid consumption and use of citrus or citrus containing products throughout the study
- •Have both breasts intact
排除标准
- •Have had cancer(s) within the past 5 years
- •Participated in another clinical interventional trial within the past 3 months
- •Uncontrolled intercurrent illness
- •Pregnant or breast feeding
- •Unable to produce nipple aspirate fluid
- •Have known allergic or sensitive reactions to skin care products, citrus or coconut oil
- •Have ongoing skin disorders such as eczema and psoriasis
研究组 & 干预措施
Limonene intervention
Experimental
干预措施: limonene containing massage oil (Other)
结局指标
主要结局
breast tissue bioavailability
时间窗: 4 weeks
limonene levels in nipple aspirate fluid after 4 weeks of intervention
次要结局
- safety(6 weeks)
研究者
研究点 (1)
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