Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
NCT ID: NCT02748746
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2018-08-31
2019-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
NCT04766489
Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
NCT07014657
Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer
NCT03648983
Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema
NCT06009666
The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life
NCT05776433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Bio-Electrical Impedance Analysis is a non-invasive method that measures extracellular fluid proportion and impedance of related extremity by an advanced low intensity electrical current passes through body. It was stated that Bio-Electrical Impedance Analysis measures impedance ratio and it is useful in detecting lymphedema in an early stage. Bio-Electrical Impedance Analysis (BIA) gives important informations in the assessment of lymphedema by measuring directly tissue fluid changes. Lymphedema Index (L-dex) is found by dividing impedance ratios of unaffected extremity to affected extremity's impedance ratio with bio-electrical impedance analysis. Impedance of extremity lessens by developing lymphedema so L-dex value gets higher.
Tissue Dielectric Constant (TDC) is an objective and non-invasive measurement method to evaluate early tissue fluid changes. A 300 megahertz signal is generated in a control unit and transmitted to tissue by probe. Reflected electromagnetic wave depends on dielectric constant of tissue. Free and bound water molecules proportion in tissue effect tissue dielectric constant. Reflected electromagnetic wave is processed in the control unit and relative tissue dielectric constant is calculated. Dielectric constant of pure water is 78.5 in room temperature. The Scale ranges between 1-80. It was stated that comparing affected and unaffected extremities regarding lymphedema existence with TDC measurement, TDC value was higher than 1.2 in the experimental group. In the control group, TDC value was lower than 1.2 . It was also emphasized that this proportion is probably valuable on assessment of upper extremity lymphedema. TDC could be done in different depth. 0.5, 1.5, 2.5 and 5.0 mm probes are possible for usage.In this study, Moisture Meter-D compact (MMDc) device will be used for assessment. It allows evaluation in 2.5 mm depth. In this study, TDC will be applied to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement.
Between 18-65 years old total 60 women will be recruited into the study in 3 separate groups.The first group will contain patients who had breast cancer surgery yet having no lymphedema. The inclusion criteria for involving the first group is surgery time. No one will be involved into the first group if surgery was applied 18 months ago before enrollment to this study. The second group will contain patients who had breast cancer surgery and having upper extremity lymphedema. The third group will contain healthy women. The aim of this study whether BIA and TDC methods are in capable of detecting lymphedema in an early stage. Measurements will be done at baseline, 6th month and 12th month. Exclusion criteria include being involuntary to recruit the study, bilaterally breast surgery history, having bilaterally upper extremity lymphedema, active infection, active chemotherapy and radiotherapy process, being in malignity period, and having mentally and cognitive disorders.
Lymphedema treatment may be quite costly due to materials used in the treatment and special producted compression stockings. If we take into account that compression stocking must change every six months, it carries too much importance regarding cost-effectivity that preventing lymphedema before manifesting.Even if lymphedema manifested already, detecting lymphedema in an early stage before aggravation improves treatment outcomes and individual's quality of life.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgery no Lymphedema
The inclusion criteria for involving the first group is surgery time. No one will be involved into the first group if surgery was applied 18 months ago before enrollment to this study. Measurements will be done at baseline, 6th month and 12th month. Tissue dielectric constant measurement will be applied to upper extremity both affected and unaffected. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. Bio impedance Analysis measurement will be done at both side. Self-adhesive electrodes will be applied related side's foot dorsum and hand dorsum. Impedance ratios will be calculated for each side then dividing process is conducted for determining L-dex ratio.
Bio Impedance Analysis Measurement
Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
Tissue Dielectric Constant Measurement
In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
Surgery having Lymphedema
The second group will contain patients who had breast cancer surgery and having upper extremity lymphedema.Measurements will be done at baseline, 6th month and 12th month. Tissue dielectric constant measurement will be applied to upper extremity both affected and unaffected. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. Bio Impedance Analysis measurement will be done at both side. Self-adhesive electrodes will be applied related side's foot dorsum and hand dorsum.Impedance ratios will be calculated for each side then dividing process is conducted for determining L-dex ratio.
Bio Impedance Analysis Measurement
Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
Tissue Dielectric Constant Measurement
In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
Healthy Women
The third group will contain healthy women. Measurements will be done at baseline, 6th month and 12th month. Tissue dielectric constant measurement will be applied to upper extremity both affected and unaffected. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. Bio Impedance Analysis measurement will be done at both side. Self-adhesive electrodes will be applied related side's foot dorsum and hand dorsum.Impedance ratios will be calculated for each side then dividing process is conducted for determining L-dex ratio.
Bio Impedance Analysis Measurement
Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
Tissue Dielectric Constant Measurement
In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bio Impedance Analysis Measurement
Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
Tissue Dielectric Constant Measurement
In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Bilaterally Breast Surgery History
* Having Bilaterally Upper Extremity Lymphedema
* Active Infection Existence
* Active Chemotherapy
* Active Radiotherapy
* Being in Malignity Period
* Having Mentally and Cognitive Disorders
18 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Scientific and Technological Research Council of Turkey
OTHER
Abant Izzet Baysal University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yeşim Bakar, Assoc. Prof
Role: STUDY_CHAIR
Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Alper Tuğral, Res. Assist
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Ümmügül Üyetürk, Assoc. Prof
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Abant Izzet Baysal University
Bolu, City Centre, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AbantIBU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.