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临床试验/NCT03391206
NCT03391206已完成不适用

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 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2016年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
1
主要终点
Brest cancer related lymphedema

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Brest cancer related lymphedema

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung Seok Park

Clinical Assistant Professor

Severance Hospital

研究点 (1)

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