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

NCT ID: NCT03391206

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-18
• Study Completion Date: 2017-08-17

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.

Conditions

Breast Cancer Lymphedemas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

presence of BCRL

presence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement

Inbody 720

Intervention Type: DIAGNOSTIC_TEST

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

absence of BCRL

absence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement

Inbody 720

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Inbody 720

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

bioelectrical impedance analysis

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyung Seok Park

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyung Seok Park, MD

Role: STUDY_CHAIR

Yonsei University College of Medicine, Korea

Locations

Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31286884 (View on PubMed)

Other Identifiers

4-2016-0149

Identifier Type: -

Identifier Source: org_study_id