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

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ClinicalTrials.gov Identifier: NCT02748746
Recruitment Status : Withdrawn (Unable to achieve device(s) which will be used in this study.)
First Posted : April 22, 2016
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Abant Izzet Baysal University

Tracking Information
First Submitted Date  ICMJE April 7, 2016
First Posted Date  ICMJE April 22, 2016
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE August 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 20, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
Official Title  ICMJE Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Lymphedema
  • Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Bio Impedance Analysis Measurement
    • Device: Tissue Dielectric Constant Measurement
  • 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.
    Interventions:
    • Device: Bio Impedance Analysis Measurement
    • Device: Tissue Dielectric Constant Measurement
  • 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.
    Interventions:
    • Device: Bio Impedance Analysis Measurement
    • Device: Tissue Dielectric Constant Measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
60
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02748746
Other Study ID Numbers  ICMJE AbantIBU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Abant Izzet Baysal University
Study Sponsor  ICMJE Abant Izzet Baysal University
Collaborators  ICMJE The Scientific and Technological Research Council of Turkey
Investigators  ICMJE
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
PRS Account Abant Izzet Baysal University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP