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Clinical Trials/NCT03391206
NCT03391206
Completed
Not Applicable

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

Severance Hospital1 site in 1 country228 target enrollmentApril 18, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Lymphedemas
Sponsor
Severance Hospital
Enrollment
228
Locations
1
Primary Endpoint
Brest cancer related lymphedema
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 18, 2016
End Date
August 17, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyung Seok Park

Clinical Assistant Professor

Severance Hospital

Eligibility Criteria

Inclusion Criteria

  • Breast cancer patients
  • 20 years of age or older who survive after surgery and follow-up

Exclusion Criteria

  • Patients with bilateral breast cancer
  • Male breast cancer patient
  • Patients with a history of previous axillary surgery or radiation
  • Recurrent breast cancer subjects
  • Those who can not read or understand the written consent of an illiterate or foreigner
  • Subjects who did not voluntarily decide to participate in this study or who did not sign a consent form
  • The subjects who were judged inappropriate by the researcher to participate in this study

Outcomes

Primary Outcomes

Brest cancer related lymphedema

Time Frame: At least six months after the surgical treatment

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.

Secondary Outcomes

  • Nutrient intake analysis(At least six months after the surgical treatment)
  • BIA(At least six months after the surgical treatment)
  • SFBIA ratio(At least six months after the surgical treatment)
  • BMI(At least six months after the surgical treatment)
  • WHR(At least six months after the surgical treatment)
  • Percent body fat(At least six months after the surgical treatment)

Study Sites (1)

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