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

Breast Cancer Clinical Trial

— BIA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02748746
• Other study ID #: AbantIBU
• Status: Withdrawn
• Phase: N/A
• Start date: August 2018
• Est. completion date: November 2019

Study information

• Verified date: June 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 impedance ratios and lymphedema index (L-dex) by using bio-electrical impedance analysis in patients after breast cancer surgery.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	City Centre

Sponsors (2)

Lead Sponsor	Collaborator
Abant Izzet Baysal University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Investigation of early detection of lymphedema after breast cancer surgery with Tissue Dielectric Constant (TDC) measurement	To investigate efficacy of Tissue Dielectric Constant (TDC) measurement method on early onset of upper extremity lymphedema.	12 months
Primary	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.	12 months
Secondary	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.	12 months