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

Breast Cancer Lymphedemas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391206
• Other study ID #: 4-2016-0149
• Status: Completed
• Phase: N/A
• First received: October 11, 2017
• Last updated: January 4, 2018
• Start date: April 18, 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: January 2018
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 17, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Lymphedemas
• Breast Neoplasms
• Lymphedema

Intervention

Diagnostic Test:
• Inbody 720
We investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement..

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At least six months after the surgical treatment
Secondary	BIA	bioelectrical impedance values	At least six months after the surgical treatment
Secondary	SFBIA ratio	single frequency bioelectrical impedance analysis	At least six months after the surgical treatment
Secondary	BMI	body mass index; weight in kilograms(kg) and height in meter(m) will be combined to report BMI in kg/m^2	At least six months after the surgical treatment
Secondary	WHR	waist-hip ratio; waist circumference in centimeter(cm) and hip circumference in centimeter(cm) will be combined to report WHR in cm/cm	At least six months after the surgical treatment
Secondary	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 (%)	At least six months after the surgical treatment
Secondary	Nutrient intake analysis	nutrient intake was analyzed by a nutrition analysis program (Can-Pro 5.0) through food frequency questionnaire	At least six months after the surgical treatment