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

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ClinicalTrials.gov Identifier: NCT03391206
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hyung Seok Park, Severance Hospital

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.

Condition or disease Intervention/treatment
Breast Cancer Lymphedemas 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : April 18, 2016
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : August 17, 2017


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 Name: 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 Name: bioelectrical impedance analysis




Primary Outcome Measures :
  1. Brest cancer related lymphedema [ Time Frame: 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.


Secondary Outcome Measures :
  1. BIA [ Time Frame: At least six months after the surgical treatment ]
    bioelectrical impedance values

  2. SFBIA ratio [ Time Frame: At least six months after the surgical treatment ]
    single frequency bioelectrical impedance analysis

  3. BMI [ Time Frame: At least six months after the surgical treatment ]
    body mass index; weight in kilograms(kg) and height in meter(m) will be combined to report BMI in kg/m^2

  4. WHR [ Time Frame: At least six months after the surgical treatment ]
    waist-hip ratio; waist circumference in centimeter(cm) and hip circumference in centimeter(cm) will be combined to report WHR in cm/cm

  5. Percent body fat [ Time Frame: At least six months after the surgical treatment ]
    body fat mass in kilograms(kg) and weight in kilograms(kg) will be combined to report Percent body fat in kg/kg*100 (%)

  6. Nutrient intake analysis [ Time Frame: At least six months after the surgical treatment ]
    nutrient intake was analyzed by a nutrition analysis program (Can-Pro 5.0) through food frequency questionnaire



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391206


Locations
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Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
Investigators
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Study Chair: Hyung Seok Park, MD Yonsei University College of Medicine, Korea

Additional Information:

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Responsible Party: Hyung Seok Park, Clinical Assistant Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT03391206     History of Changes
Other Study ID Numbers: 4-2016-0149
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Hyung Seok Park, Severance Hospital:
Breast cancer related lymphedemas
Sentinel Lymph Node Biopsy
Axillary Lymph Node Dissection
Bioelectrical Impedance Analysis
Dietary Fat

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes