A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To evaluate the incidence of lymphedema in upper arm after ALND
研究概览
简要总结
Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study.
The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.
详细描述
Primary Objectives:
- To analyze incidence rate of lymphedema using tape measurements, perometre, bioimpedance, spectroscopy.
Secondary Objectives:
- To determine the risk factor of lymphedema in postoperative breast cancer.
- To understand that lymphedema has an effect on quality of life and physical function in postoperative breast cancer.
- To complete uestionnaire about physical and quality of life in postoperative breast cancer with ALND patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 20 years old
- •Patient who underwent unilateral Breast Cancer surgery with ALND
- •Informed consent must to be signed
排除标准
- •Previous history of breast cancer
- •History of abnormality or vascular disease in upper extremity
- •Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- •History of infection on upper extremity
- •History of corticosteroid use on whole body for any reason
- •Inability to provide informed consent (e.g. dementia or severe cognitive impairment)
结局指标
主要结局
To evaluate the incidence of lymphedema in upper arm after ALND
时间窗: Up to 1year
In this study, we evaluated the incidence of lymphedema in upper arm using tape measurement, perometre and bioimpedance spectroscopy during pre,post-operative visit, 3, 6, 9month and 1year clinical follow-up.
次要结局
- Physical assess(Up to 1year)
- To Evaluate quality of life using questionnaire(Up to 1year)
研究者
So-Youn Jung
Medical Doctor
National Cancer Center, Korea