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

NCT ID: NCT01969253

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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So-Youn Jung

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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So-Youn Jung

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCC-1210181-2

Identifier Type: -

Identifier Source: org_study_id

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