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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Lymphedemas
• Intervention / Treatment: Diagnostic test: Inbody 720

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.

• Study Type: Observational
• Enrollment (Actual): 228

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
presence of BCRL; presence 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..; Other Names: bioelectrical impedance analysis
absence of BCRL; 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..; Other Names: bioelectrical impedance analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIA	bioelectrical impedance values	At least six months after the surgical treatment
SFBIA ratio	single frequency bioelectrical impedance analysis	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	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	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 (%)	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	At least six months after the surgical treatment

Collaborators and Investigators

• Sponsor: Severance Hospital
• Investigators: Study Chair: Hyung Seok Park, MD, Yonsei University College of Medicine, Korea

Publications and helpful links

General Publications

• Lim SM, Han Y, Kim SI, Park HS. Utilization of bioelectrical impedance analysis for detection of lymphedema in breast Cancer survivors: a prospective cross sectional study. BMC Cancer. 2019 Jul 8;19(1):669. doi: 10.1186/s12885-019-5840-9.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2016
• Primary Completion (Actual): April 18, 2017
• Study Completion (Actual): August 17, 2017

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Breast cancer related lymphedemas; Sentinel Lymph Node Biopsy; Axillary Lymph Node Dissection; Bioelectrical Impedance Analysis; Dietary Fat
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 4-2016-0149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No