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

NCT02748746 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-04

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER
  • Abant Izzet Baysal University

    lead OTHER

Principal Investigators

  • Yeşim Bakar, Assoc. Prof · Abant Izzet Baysal University School of Physical Therapy and Rehabilitation

  • Alper Tuğral, Res. Assist · Abant Izzet Baysal University School of Physical Therapy and Rehabilitation

  • Ümmügül Üyetürk, Assoc. Prof · Abant Izzet Baysal University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-05-31
Completion
2019-11-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748746 on ClinicalTrials.gov