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

National Cancer Center (NCC)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01969253

NCC-1210181-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)