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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969253
• Other study ID #: NCC-1210181-2
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: October 13, 2015
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Physical assess	Questionnaire: Disabilities of the arm shoulder and hand using (DASH); Physical examination	Up to 1year	Yes