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Trial record 3 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery (BIA)

This study is not yet open for participant recruitment.
Verified June 2017 by Abant Izzet Baysal University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748746
First Posted: April 22, 2016
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Tubitak
Information provided by (Responsible Party):
Abant Izzet Baysal University
  Purpose
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.

Condition Intervention
Lymphedema Breast Cancer Device: Bio Impedance Analysis Measurement Device: Tissue Dielectric Constant Measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Abant Izzet Baysal University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Investigation of symptom related quality of life with LymQoL [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  • Investigation of early detection of lymphedema after breast cancer surgery with Tissue Dielectric Constant (TDC) measurement [ Time Frame: 12 months ]
    To investigate efficacy of Tissue Dielectric Constant (TDC) measurement method on early onset of upper extremity lymphedema.


Estimated Enrollment: 60
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Other Name: Bio Electrical Impedance Analysis
Device: 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 Name: TDC
Experimental: 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.
Device: 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.
Other Name: Bio Electrical Impedance Analysis
Device: 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 Name: TDC
Active Comparator: 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.
Device: 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.
Other Name: Bio Electrical Impedance Analysis
Device: 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 Name: TDC

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being Voluntary to recruit study

Exclusion Criteria:

  • 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
  Contacts and Locations
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): NCT02748746


Contacts
Contact: Yeşim Bakar, Assoc. Prof +905065868751 ptyesim@yahoo.de
Contact: Alper Tuğral, Res. Assist +905074421420 tugral.alper@gmail.com

Locations
Turkey
Abant Izzet Baysal University Not yet recruiting
Bolu, City Centre, Turkey, 14280
Contact: Yeşim Bakar, Assoc.Prof    +905065868751    ptyesim@yahoo.de   
Contact: Alper Tuğral, Res.Assist    +905074421420    tugral.alper@gmail.com   
Principal Investigator: Yeşim Bakar, Assoc.Prof         
Principal Investigator: Alper Tuğral, Res.Assist         
Principal Investigator: Ümmügül Üyetürk, Assoc.Prof         
Sponsors and Collaborators
Abant Izzet Baysal University
Tubitak
Investigators
Study Chair: Yeşim Bakar, Assoc. Prof Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Principal Investigator: Alper Tuğral, Res. Assist Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
Principal Investigator: Ümmügül Üyetürk, Assoc. Prof Abant Izzet Baysal University School of Medicine
  More Information

Responsible Party: Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT02748746     History of Changes
Other Study ID Numbers: AbantIBU
First Submitted: April 7, 2016
First Posted: April 22, 2016
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abant Izzet Baysal University:
Lymphedema
Electric Impedance
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases