Clinical trial NCT01969253: A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection
Official title: A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer, Axillary Lymph Node Dissection, Lymphedema
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-10-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the incidence of lymphedema in upper arm after ALND
timeFrame: Up to 1year
Secondary outcomes:
measure: To Evaluate quality of life using questionnaire
timeFrame: Up to 1year
measure: Physical assess
timeFrame: Up to 1year
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: So-Youn Jung
role: PRINCIPAL_INVESTIGATOR
References: