Clinical Trials Directory

Trials / Completed

CompletedNCT03391206

Bioelectrical Impedance Utilization and Dietary Intake Relation in the Breast Cancer Related Lymphedema

Relationship Between Bioelectrical Impedance Utilization and Dietary Intake in the Analysis of Risk of Lymphedema in Breast Cancer Survivors: A Prospective Cross Sectional Study

Status
Completed
Phase
Study type
Observational
Enrollment
228 (actual)
Sponsor
Severance Hospital · Academic / Other
Sex
Female
Age
20 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTInbody 720We investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement..

Timeline

Start date
2016-04-18
Primary completion
2017-04-18
Completion
2017-08-17
First posted
2018-01-05
Last updated
2018-01-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03391206. Inclusion in this directory is not an endorsement.