A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Skin thickness measurements
研究概览
简要总结
Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema.
Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
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
- 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
- •Ages 18 to 75 years (inclusive)
- •Patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy
- •Free of distant metastasis in preoperative screening
- •Histology results of axillary lymph nodes could be either Negative or Positive
- •Patients who undergo preoperative chemotherapy can be included
- •Willingness and ability to provide written informed consent
- •Willingness and ability to comply with all study procedures
排除标准
- •Primary lymphedema of the affected upper limb
- •Secondary lymphedema of the affected limb prior to the lymphadenectomy
- •Radiotherapy at the axilla before the study / surgery
- •Allergic reaction to porcine collagen or ICG
- •Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery
- •Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening
- •Other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis
- •Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
- •Either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio>1.1 or R0 bioimpedance ratio > 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk.
- •Life expectancy < 2 years for any reason
- •Pregnancy or nursing
- •Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
- •Severe psychiatric disease
- •Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
- •Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
- •Absolute neutrophil count < 1500 mm3 at screening
- •Hemoglobin concentration < 9 g/dL at screening
- •Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study
研究组 & 干预措施
Group C
Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.
干预措施: axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) (Procedure)
Group A
Group A will under axillary lymphadenectomy alone
干预措施: Axillary lymphadenetomy alone (Procedure)
Group B
Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)
干预措施: axillary lymphadenectomy with soft tissue reinforcement (Procedure)
结局指标
主要结局
Skin thickness measurements
时间窗: 2 yr
Skin thickness is changed by lymphedema
Limb Volume
时间窗: 2 yr
Limb volume as measured by serial assessment
Lymphatic flow pattern of whole limb
时间窗: 2 yr
In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.
Bioiimpedance spectroscopy
时间窗: 2 yr
Impedance of the skin changes with lymphedema
Quality of life
时间窗: 2 yr
Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score
Quality of Life- Limb-Lymphedema-Specific Quality of Life (LYMQOL)
时间窗: 2 yr
Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score. Domain scores range from 0 to 4, with higher scores indicating greater impairment and worse quality of life. An additional overall quality of life score ranges from 0 to 10, with higher scores indicating better overall quality of life.
次要结局
未报告次要终点