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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This prospective study is observational study that focused on incidence of lymphedema in breast cancer patients. Annually six hundred patients have received treatment of breast cancer from the breast cancer center at National Cancer Center in Korea. Among of them, two hundred patients have received surgical treatment with axillary dissection. About four hundred patients were recruited consecutively for enrollment from May 2012 to December 2013.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer, Axillary Lymph Node Dissection, Lymphedema
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: NCC-1210181-2