NCT02748746

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

April 7, 2016

Last Update Submit

June 1, 2020

Conditions

LymphedemaBreast Cancer

Keywords

LymphedemaElectric ImpedanceBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Investigation of symptom related quality of life with LymQoL

    12 months

Other Outcomes (1)

  • Investigation of early detection of lymphedema after breast cancer surgery with Tissue Dielectric Constant (TDC) measurement

    12 months

Study Arms (3)

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.

Device: Bio Impedance Analysis MeasurementDevice: 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.

Device: Bio Impedance Analysis MeasurementDevice: 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.

Device: Bio Impedance Analysis MeasurementDevice: Tissue Dielectric Constant Measurement

Interventions

Bio Impedance Analysis MeasurementDEVICE

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.

Also known as: Bio Electrical Impedance Analysis
Healthy WomenSurgery having LymphedemaSurgery no Lymphedema
Tissue Dielectric Constant MeasurementDEVICE

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.

Also known as: TDC
Healthy WomenSurgery having LymphedemaSurgery no Lymphedema

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being Voluntary to recruit study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, City Centre, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yeşim Bakar, Assoc. Prof

    Abant Izzet Baysal University School of Physical Therapy and Rehabilitation

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 22, 2016

Study Start

August 1, 2018

Primary Completion

May 1, 2019

Study Completion

November 1, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Locations

TU(1)