A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 20 years old Patient who underwent unilateral Breast Cancer surgery with ALND Informed consent must to be signed Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of lymphedema in upper arm after ALND | 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. | Up to 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate quality of life using questionnaire | European Organization for Research and Treatment of Cancer(EORTC) the 30-item version of the core Quality of Life Questionnaire (EORTC QLQ C30) EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR23) | Up to 1year | 
| Physical assess | Questionnaire: Disabilities of the arm shoulder and hand using (DASH) Physical examination | Up to 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Axillary Lymph Node Dissection, Lymphedema