LymphedemaBIANCT02748746
Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
A study testing Bio Impedance Analysis Measurement and Tissue Dielectric Constant Measurement in people with Lymphedema and Breast Cancer, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective methods in clinical usage to detect lymphedema in early stage. The aim of this study is to reveal comparative relation these two methods on detecting lymphedema in an early stage.The another aim of this study is to determine… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Bio Impedance Analysis Measurement and Tissue Dielectric Constant Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2018to Nov 2019
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being Voluntary to recruit study
Who cannot join
- Being involuntary to recruit the study
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu, City Centre, 14280
About this study
Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective methods in clinical usage to detect lymphedema in early stage. The aim of this study is to reveal comparative relation these two methods on detecting lymphedema in an early stage.The another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by using bio-electrical impedance analysis in patients after breast cancer surgery.
Read the detailed description
Lymphedema is characterized by accumulation of protein rich fluid in interstitial spaces. It is also a chronic condition that needs lifelong care. Untreated lymphedema leads to chronic inflammation, cellulitis, pain, tiredness, cosmetic deformities, restriction of individual's motion, mobility problems and dysfunctional use of affected extremity. Undiagnosed lymphedema worsens gradually thus detecting lymphedema in an early stage have a place in matter. It was indicated that early treatment of lymphedema improves treatment outcomes.
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
- Lymphedema, Breast Cancer
- Being tested
- Bio Impedance Analysis Measurement, Tissue Dielectric Constant Measurement
- Keywords
- Lymphedema, Electric Impedance, Breast Cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio Impedance Analysis MeasurementDevice
Also called Bio Electrical Impedance Analysis
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 MeasurementDevice
Also called TDC
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery no Lymphedema | Experimental | 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. Receives: Device: Bio Impedance Analysis Measurement; Device: Tissue Dielectric Constant Measurement |
| Surgery having Lymphedema | Experimental | 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. Receives: Device: Bio Impedance Analysis Measurement; Device: Tissue Dielectric Constant Measurement |
| Healthy Women | Active comparator | 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. Receives: Device: Bio Impedance Analysis Measurement; Device: Tissue Dielectric Constant Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of early detection of lymphedema after breast cancer surgery with Bio Electrical Impedance Analysis (BIA)
To investigate efficacy of Bio electrical Impedance analysis method on early onset of upper extremity lymphedema.
Measured: 12 months
Secondary outcomes (1)
Investigation of symptom related quality of life with LymQoL
Symptom related quality of life questionnaire (LympQoL) will be implemented to 60 women in 3 different time frames (baseline, 6th month and 12th month). Purpose of this whether symptomatic severity changes effect the quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startAug 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: Unable to achieve device(s) which will be used in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Yeşim Bakar, Assoc. Prof, Study chair, Abant Izzet Baysal University School of Physical Therapy and RehabilitationAlper Tuğral, Res. Assist, Principal investigator, Abant Izzet Baysal University School of Physical Therapy and RehabilitationÜmmügül Üyetürk, Assoc. Prof, Principal investigator, Abant Izzet Baysal University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748746
- Sponsor's protocol ID
- AbantIBU
- Acronym
- BIA
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02748746
- Acronym / sponsor ID
- BIA / AbantIBU
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Lymphedema, Electric Impedance, Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to achieve device(s) which will be used in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Aug 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective methods in clinical usage to detect lymphedema in early stage. The aim of this study is to reveal comparative relation these two methods on detecting lymphedema in an early stage.The another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by using bio-electrical impedance analysis in patients after breast cancer surgery.
Detailed description
Lymphedema is characterized by accumulation of protein rich fluid in interstitial spaces. It is also a chronic condition that needs lifelong care. Untreated lymphedema leads to chronic inflammation, cellulitis, pain, tiredness, cosmetic deformities, restriction of individual's motion, mobility problems and dysfunctional use of affected extremity. Undiagnosed lymphedema worsens gradually thus detecting lymphedema in an early stage have a place in matter. It was indicated that early treatment of lymphedema improves treatment outcomes.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery no Lymphedema | Experimental | Device: Bio Impedance Analysis Measurement, Device: Tissue Dielectric Constant MeasurementThe 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. |
| Surgery having Lymphedema | Experimental | Device: Bio Impedance Analysis Measurement, Device: Tissue Dielectric Constant MeasurementThe 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. |
| Healthy Women | Active comparator | Device: Bio Impedance Analysis Measurement, Device: Tissue Dielectric Constant MeasurementThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being Voluntary to recruit study
Key exclusion criteria (8 listed)
- Being involuntary to recruit the study
- Bilaterally Breast Surgery History
- Having Bilaterally Upper Extremity Lymphedema
- Active Infection Existence
- Active Chemotherapy
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 |
|---|---|---|
| Bio Impedance Analysis MeasurementAlso: Bio Electrical Impedance AnalysisSelf-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. | Device | Healthy Women, Surgery having Lymphedema, Surgery no Lymphedema |
| Tissue Dielectric Constant MeasurementAlso: TDCIn 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. | Device | Healthy Women, Surgery having Lymphedema, Surgery no Lymphedema |
Primary outcome
Investigation of early detection of lymphedema after breast cancer surgery with Bio Electrical Impedance Analysis (BIA)
Time frame: 12 months
To investigate efficacy of Bio electrical Impedance analysis method on early onset of upper extremity lymphedema.
1 secondary outcome
Investigation of symptom related quality of life with LymQoL
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Yes
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A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
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The Effectiveness of Lymphatic Bypass Supermicrosurgery
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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.
Yeşim Bakar, Assoc. Prof study chair
Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Alper Tuğral, Res. Assist principal investigator
Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Ümmügül Üyetürk, Assoc. Prof principal investigator
Abant Izzet Baysal University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio Impedance Analysis Measurement and Tissue Dielectric Constant Measurement in people with Lymphedema and Breast Cancer, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. 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 Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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?
Investigation of early detection of lymphedema after breast cancer surgery with Bio Electrical Impedance Analysis (BIA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.