A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection
A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republiken av, 410-769
- National Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To evaluate the incidence of lymphedema in upper arm after ALND
Tidsram: 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.
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Up to 1year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To Evaluate quality of life using questionnaire
Tidsram: Up to 1year
|
|
Up to 1year
|
|
Physical assess
Tidsram: Up to 1year
|
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Up to 1year
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCC-1210181-2
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