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

NCT01969253 | Completed DMC

• 1 other identifier: NCC-1210181-2
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer, Axillary Lymph Node Dissection, Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To Evaluate quality of life using questionnaire

  Up to 1year

• Physical assess

  Up to 1year

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Older than 20 years old
• Patient who underwent unilateral Breast Cancer surgery with ALND
• Informed consent must to be signed

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• So-Youn Jung

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: October 25, 2013
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

KR (1)