NCT06144164招募中3 期
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 14
- 主要终点
- The difference between the baseline and postoperative arm volume measurement
研究概览
简要总结
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Diagnosis of breast cancer
- •Ages 18 to 75 years
- •Consented for unilateral ALND or for unilateral SLNB with possible ALND
排除标准
- •Does not speak English
- •Does not fit into study garment
- •Axillary recurrence
- •History of ALND
- •Requirement of bilateral ALND for the treatment of breast cancer
- •Treatment with SLNB only
- •Known anaphylactic allergy to ICG dye used in ILR
- •Impaired decision-making capacity
结局指标
主要结局
The difference between the baseline and postoperative arm volume measurement
时间窗: Up to 24 months
The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
次要结局
未报告次要终点
研究者
研究点 (14)
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