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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01969253
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of lymphedema in upper arm after ALND	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.

Secondary Outcome Measures

Name	Time	Method
Physical assess	Up to 1year	* Questionnaire: Disabilities of the arm shoulder and hand using (DASH); * Physical examination
To Evaluate quality of life using questionnaire	Up to 1year	* 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)

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of