Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein
研究概览
简要总结
This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.
详细描述
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
OUTLINE: This is a phase I study followed by a randomized phase II study.
PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
After completion of study treatment, patients are followed up periodically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
排除标准
- •Prior lymphedema in either arm
- •Prior history of axillary surgery (except for sentinel node biopsies)
- •Prior history of chest/axillary radiation
- •Need for bilateral axillary node dissection surgery
- •Prior neurologic deficits (either motor or sensory) in ipsilateral arm
- •Known allergy to vital blue dyes
- •No prior diagnosis of inflammatory breast cancer
- •Cannot be pregnant or planning to continue breast-feeding immediately after surgery
研究组 & 干预措施
Arm I (reverse mapping guided axillary lymph node dissection)
Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
干预措施: isosulfan blue based lymphatic mapping (Drug)
Arm I (reverse mapping guided axillary lymph node dissection)
Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
干预措施: axillary lymph node dissection (Procedure)
Arm I (reverse mapping guided axillary lymph node dissection)
Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
干预措施: quality-of-life assessment (Procedure)
Arm I (reverse mapping guided axillary lymph node dissection)
Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
干预措施: Questionnaire administration (Other)
Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
干预措施: isosulfan blue based lymphatic mapping (Drug)
Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
干预措施: axillary lymph node dissection (Procedure)
Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
干预措施: quality-of-life assessment (Procedure)
Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
干预措施: Questionnaire administration (Other)
结局指标
主要结局
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein
时间窗: Up to 4 years
A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.
Percentage of Patients With Lymphedema
时间窗: Up to 4 years
Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes
时间窗: Up to 4 years
A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.
次要结局
未报告次要终点