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NCT Number: NCT01969253

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Cancer Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. To evaluate the incidence of lymphedema in upper arm after ALND

    Time frame: 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 outcomes

  1. To Evaluate quality of life using questionnaire

    Time frame: 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)

  2. Physical assess

    Time frame: Up to 1year

    • Questionnaire: Disabilities of the arm shoulder and hand using (DASH)
    • Physical examination

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2013
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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