Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Deterioration of dermal backflow
研究概览
简要总结
Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (>= 3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.
Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet.
This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.
详细描述
Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Estimates of incidence rates have varied over time, especially since the progression to less invasive techniques as sentinel node procedures and radiotherapy. According to a review article of DiSipio the incidence of arm lymphedema was about four times higher in women who had an axillary lymph node dissection (18 studies; 19.9%, 13.5-28.2) than in those who had sentinel lymph node biopsy (18 studies; 5.6%, 6.1-7.9). Several other risk factors are already suggested as having a negative impact on the development of lymphedema such as BMI and chemotherapy. A comprehensive overview of all treatment related risk factors and patient related risk factors, including demographics, has not been reported yet.
Lymphedema is identified with upper limb volume measurements eg circumference measurements, water displacement and perometer. Bioimpedance spectroscopy can also be used to assess the extracellular fluid. A 10% limb volume change has been reported as the most accurate threshold to diagnose lymphedema. However, with this definition an underestimation of the incidence rate of lymphoedema is made. Therefore, recently a threshold of 5% limb volume change is proposed.
A study by Rockson et al suggested that in almost 75 % of the cases, lymphoedema is established in the first year after breast cancer treatment. But up to two years after surgery, there still is a possibility to develop lymphoedema.
Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (>= 3% volume change) that recognizes subclinical lymphedema is promoted.
When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18y (since the investigation using ICG is not dangerous for pregnant women, women with child bearing age are included)
- •Women/ men with breast cancer and scheduled for unilateral axillary lymph node dissection (ALND) or sentinel node biopsy (SNB)
- •Oral and written approval of informed consent
- •Dutch speaking
排除标准
- •Oedema of the upper limb from other causes
- •Cannot participate during the entire study period
- •Mentally or physically unable to participate in the study
- •Contra-indication for the use of ICG: allergy to iodine, hyperthyroidism
- •Metastatic disease
结局指标
主要结局
Deterioration of dermal backflow
时间窗: up to 36 months
measured by lymphofluoroscopy
Incidence of lymphedema of arm and hand
时间窗: up to 36 months
defined as 5% volume increase compared to the contralateral side
次要结局
- change of pitting status(up to 36 months)
- relative change of arm volume difference(up to 36 months)
- Change of extracellular fluid change of extracellular fluid(up to 36 months)
- Change of quality of life(up to 36 months)
- Change of water content(up to 36 months)
- severity of disturbance of lymphatic transport(up to 36 months)
- problems in functioning related to development of lymphedema(up to 36 months)
- change of skinfold tickness(up to 36 months)
研究者
dr. Sarah Thomis
Vascular Surgeon
Universitaire Ziekenhuizen KU Leuven