An observational study in Breast Cancer Lymphedemas, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Severance Hospital · Observational
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The purpose of this study was to investigate the clinical role of bioelectrical impedance analysis (BIA) and the relationship between the occurrence of breast cancer related lymphedema (BCRL) and dietary factors in breast cancer survivors who underwent surgical treatments.
Breast cancer survivors are at risk of complications of breast cancer-related lymphedema (BCRL) after surgical treatments, which may negatively effect on the quality of life of breast cancer survivors. Lymphedema has been clinically diagnosed by determining that a limb is in fact swollen, and has arbitrarily been diagnosed in other etiologies. Limb circumference differences of 2 cm, a 200 mL or more in limb, or a 5% volume change are some of the objective ways that clinicians use to diagnose lymphedema. Although the arm circumference measurement method is a simple and frequently used clinical method, there is a disadvantage that the standardized reference point does not exist, the extracellular space can not be measured, and the sensitivity is also low. The lack of evidence-based diagnostic criteria to define lymphedema has presented tremendous difficulty in diagnosing lymphedema. It is important to define such criteria for early detection and treatment of lymphedema. Because of these limitations, many researchers are studying various methods for diagnosing lymphadenopathy and methods of bioelectrical impedance have been studied, recently.
Bioelectrical Impedance predicts body composition using the difference of electric conductivity by flowing a minute current to human body.This principle is used to diagnose the occurrence of lymphatic edema. In several studies, the single-frequency bioimpedance analysis (SFBIA) of the two arms obtained from bioelectrical impedance measurements was expressed as the ratio of the values of the operated and non-operated arms. However, it has not yet been clarified as a diagnostic method. Therefore, more studies are needed to establish a diagnosis method and a prediction method of lymphatic edema.
Various risk factors of lymphedema such as axillary lymph node dissection (ALND) and obesity have been studied for early prevention. However, there are no studies on the relationship between breast cancer related lymphedema, and dietary factors in breast cancer patients. The purpose of this study was to compare the diagnosis of lymphedema with the measurement of the arm circumference and the diagnosis of lymphedema through bioelectrical impedance values in order to clarify the clinical role of bioelectrical impedance method as a diagnostic method of lymphedema. To investigate the relationship between dietary factors, which are considered to be related to the occurrence of lymphedema, the investigators examined the frequency of dietary intake and analyzed the relationship between dietary factors and lymphatic edema.
124 studies on the registry are indexed under Breast Cancer Lymphedema; 39 are open to participants now.
This study's enrollment of 228 is above the median of 80 across 25 observational studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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This study was conducted on women who were followed up at Severance Hospital for breast cancer survivors aged 20 years or older. Unilateral breast cancer patients at least 6 months after surgery were selected. They were voluntarily participated. The total number of patients recruited in this study was 250. Of these, 228 patients were enrolled, except for 10 patients with bilateral breast cancer, 10 patients with poor medical records, and 2 patients who did not measure bioelectrical impedance. 228 patients diagnosed lymphedema by arm circumference measurement.
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Exclusion Criteria:
presence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement
Diagnostic Test: Inbody 720
absence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement
Diagnostic Test: Inbody 720
We investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement..
Also known as: bioelectrical impedance analysis
Brest cancer related lymphedema
Assessed by measuring the circumference at 15.0 centimeter below the acromion process in both arm and circumference difference of greater than or equal to 2.0 centimeter.
Time frame: At least six months after the surgical treatment
BIA
bioelectrical impedance values
Time frame: At least six months after the surgical treatment
SFBIA ratio
single frequency bioelectrical impedance analysis
Time frame: At least six months after the surgical treatment
BMI
body mass index; weight in kilograms(kg) and height in meter(m) will be combined to report BMI in kg/m\^2
Time frame: At least six months after the surgical treatment
WHR
waist-hip ratio; waist circumference in centimeter(cm) and hip circumference in centimeter(cm) will be combined to report WHR in cm/cm
Time frame: At least six months after the surgical treatment
Percent body fat
body fat mass in kilograms(kg) and weight in kilograms(kg) will be combined to report Percent body fat in kg/kg\*100 (%)
Time frame: At least six months after the surgical treatment
Nutrient intake analysis
nutrient intake was analyzed by a nutrition analysis program (Can-Pro 5.0) through food frequency questionnaire
Time frame: At least six months after the surgical treatment
Plan to share: No
Ran from Apr 2016 to primary completion in Apr 2017, 12 months.
Of 12 observational studies under Breast Cancer Lymphedema, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 12 months is close to that.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Severance Hospital