NCT00214032已完成2 期
Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- reduction of arm lymphedema
研究概览
简要总结
The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •> 6 months from last surgical and/or radiation treatment to the affected axilla
- •Unilateral lymphedema of the upper extremity
排除标准
- •May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study
研究组 & 干预措施
1
Experimental
pycnogenol daily
干预措施: Pycnogenol (Drug)
2
Placebo Comparator
placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
reduction of arm lymphedema
时间窗: monthly
次要结局
- comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire(monthly)
研究者
研究点 (1)
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