Clinical trial NCT03391206: Bioelectrical Impedance Utilization and Dietary Intake Relation in the Breast Cancer Related Lymphedema
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Lymphedemas
Keywords: Breast cancer related lymphedemas
Sentinel Lymph Node Biopsy
Axillary Lymph Node Dissection
Bioelectrical Impedance Analysis
Dietary Fat
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 228
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Brest cancer related lymphedema
timeFrame: At least six months after the surgical treatment
Secondary outcomes:
measure: BIA
timeFrame: At least six months after the surgical treatment
measure: SFBIA ratio
timeFrame: At least six months after the surgical treatment
measure: BMI
timeFrame: At least six months after the surgical treatment
measure: WHR
timeFrame: At least six months after the surgical treatment
measure: Percent body fat
timeFrame: At least six months after the surgical treatment
measure: Nutrient intake analysis
timeFrame: At least six months after the surgical treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University College of Medicine, Korea
name: Hyung Seok Park, MD
role: STUDY_CHAIR
References:
citation: 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.