A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- the number of patients that had a decrease incidence of lymphedema
研究概览
简要总结
The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include:
Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 breast cancer patients 18-75 years of age
- •Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
- •Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
排除标准
- •Male breast cancer patients
- •Non-English speaking participants
- •Female breast cancer patients with axillary recurrence
- •Female breast cancer patients who have a history of ALND
- •Female patients requiring bilateral ALND for the treatment of their breast cancer
- •Female breast patients treated with SLNBx only
结局指标
主要结局
the number of patients that had a decrease incidence of lymphedema
时间窗: up to 2 years
as measured by arm volume will be a ≥10% increase in arm volume
次要结局
未报告次要终点