NCT00188604已完成2 期
A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
研究概览
简要总结
The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
- •patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
- •ECOG performance 0-2
- •informed consent
排除标准
- •active cellulitis/skin infection of the limb
- •venous thrombosis of the upper limbs
- •active malignancy
- •any other medical condition or congenital or traumatic injury involving either limb
- •patients already on selenium medication
- •patients participating in another clinical study related to lymphedema
结局指标
主要结局
To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
次要结局
- To assess the toxicity of selenium.
- To assess the association of selenium, quality of life and limb function.
研究者
研究点 (2)
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