Breast Cancer LymphedemasNCT03391206
Bioelectrical Impedance Utilization and Dietary Intake Relation in the Breast Cancer Related Lymphedema
An observational study of Breast Cancer Lymphedemas, run by Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedemas
- What is being tested?
- Inbody 720
- How many people
- 228 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2016to 17 Aug 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Breast cancer patients
- 20 years of age or older who survive after surgery and follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Inbody 720
- Keywords
- Breast cancer related lymphedemas, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Bioelectrical Impedance Analysis, Dietary Fat
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inbody 720Diagnostic test
Also called bioelectrical impedance analysis
We investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement..
| Study group | Role | What they receive |
|---|---|---|
| presence of BCRL | presence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement Receives: Diagnostic Test: Inbody 720 | |
| absence of BCRL | absence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement Receives: Diagnostic Test: Inbody 720 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least six months after the surgical treatment
Secondary outcomes (6)
BIA
bioelectrical impedance values
Measured: At least six months after the surgical treatment
SFBIA ratio
single frequency bioelectrical impedance analysis
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Measured: At least six months after the surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start18 Apr 2016
- Primary completion18 Apr 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Seok Park, Severance Hospital
- Investigators
- Hyung Seok Park, MD, Study chair, Yonsei University College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391206
- Sponsor's protocol ID
- 4-2016-0149
- Status last verified
- Jan 2018
- First submitted
- 11 Oct 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31286884
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03391206
- Acronym / sponsor ID
- 4-2016-0149
- Conditions
- Breast Cancer Lymphedemas
- Keywords
- Breast cancer related lymphedemas, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Bioelectrical Impedance Analysis, Dietary Fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| presence of BCRL | – | Diagnostic Test: Inbody 720presence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement |
| absence of BCRL | – | Diagnostic Test: Inbody 720absence of breast cancer related lymphedema after surgical treatment using Inbody 720 and arm circumference measurement |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Breast cancer patients
- 20 years of age or older who survive after surgery and follow-up
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inbody 720Also: bioelectrical impedance analysisWe investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement.. | Diagnostic test | absence of BCRL, presence of BCRL |
Primary outcome
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.
6 secondary outcomes
BIA
Time frame: At least six months after the surgical treatment
SFBIA ratio
Time frame: At least six months after the surgical treatment
BMI
Time frame: At least six months after the surgical treatment
WHR
Time frame: At least six months after the surgical treatment
Percent body fat
Time frame: At least six months after the surgical treatment
Nutrient intake analysis
Time frame: At least six months after the surgical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 31286884Lim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Seok Park, MD study chair
Yonsei University College of Medicine, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Lymphedemas, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brest cancer related lymphedema (time frame: At least six months after the surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.