Diagnostic Accuracy of Dermal Thickness in Lymphedema

December 19, 2018 updated by: Marmara University

Diagnostic Accuracy of Between Side Differences of Ultrasonographic Dermal Thickness Measurements in Breast Cancer Related Arm Lymphedema

Ultrasound is an easily feasible noninvasive technique which is widely used in rehabilitation settings. Measurement of dermal thickness via ultrasound can be less time consuming than volume measurements with water displacement and circumference measurements. Measurement of subcutaneous tissue thickness were used for both assessment and treatment outcome. Recently reliability of ultrasound examination of thickness of the skin and subcutaneous tissue were studied by Han et al. However, diagnostic accuracy of this method has not been studied before. Early identification of breast cancer related lymphedema to start treatment earlier is critical. Consequently, reliability and diagnostic accuracy of the assessment techniques of lymphedema is crucial to evaluate both severity at the time of diagnosis, and later effectiveness of treatment. The aim of this study was to establish diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer related arm lymphedema is a potential sequalae from the treatment of breast cancer which is characterized by the accumulation of protein-rich lymphatic fluid in the extracellular spaces. It may occur in almost 40% of the patients who have undergone breast cancer surgery or radiation therapy. Breast cancer related lymphedema may appear in the upper extremity, as well as in the ipsilateral upper quadrant and remaining breast tissue. Clinically, the diagnosis of lymphedema is based mainly on patient history and self-report of symptoms, visual inspection and skin palpation, and the determination of volume differences between both limbs. The most widely accepted measure of lymphedema is limb volume compared with that of the unaffected limb or compared with that of the same limb. Sequential circumference measurements along designated measure points are widely used in clinical practice. Limb volumes can be calculated or estimated based on a truncated cone formula. Volumetry by means of water displacement is considered the golden standard. The most common criterion for lymphedema diagnosis is a volume difference of 200 mL. Circumference measurements and the estimated volume were found to be reliable and highly correlated with each other. However, these volume measurements are not only influenced by fluid changes but also by compositional changes of muscle mass, bone, or fat. Also, water displacement is too cumbersome and messy to be used in routine clinical practice.

Ultrasound is an easily feasible noninvasive technique which is widely used in rehabilitation settings. Measurement of dermal thickness via ultrasound can be less time consuming than volume measurements with water displacement and circumference measurements. Measurement of subcutaneous tissue thickness were used for both assessment and treatment outcome. Recently reliability of ultrasound examination of thickness of the skin and subcutaneous tissue were studied by Han et al. However, diagnostic accuracy of this method has not been studied before. Early identification of breast cancer related lymphedema to start treatment earlier is critical. Consequently, reliability and diagnostic accuracy of the assessment techniques of lymphedema is crucial to evaluate both severity at the time of diagnosis, and later effectiveness of treatment. The aim of this study was to establish diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema. Patients with breast cancer related lymphedema will be included. Lymphedema of the limbs will be assessed using the circumferential method. The circumferential upper limb measurementswill be carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) will be used to convert these values into limb volumes in milliliters. Differences in volume of affected and unaffected sides was defined as edema (volume difference). The criterion for lymphedema diagnosis is volume difference of 200 mL. Ultrasonographic dermal thickness measurements will be performed from medial forearm. Differences of the affected and unaffected sides will be calculated. The circumference measurement method and the thickness of the skin of the edematous limb by using the ultrasound and the truncated cone method by using circumference measurements will be compared to evaluate the diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Esra Giray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with breast cancer related lymphedema

Description

Inclusion Criteria:

1. Patients with unilateral postmastectomy lymphedema

Exclusion Criteria:

  1. Bilateral lymphedema
  2. The patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
ultrasonographic dermal thickness measurements in patients with unilateral breast cancer related lymphedema
Other: ultrasonographic dermal thickness measurements
ultrasonographic dermal thickness measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve
Time Frame: Day 0
Area under curve
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensivity of between side differences of ultrasonographic dermal thickness measurements
Time Frame: Day 0
Sensivity of between side differences of ultrasonographic dermal thickness measurements
Day 0
Specificity of between side differences of ultrasonographic dermal thickness measurements
Time Frame: Day 0
Specificity of between side differences of ultrasonographic dermal thickness measurements
Day 0
Interlimb volume difference
Time Frame: Day 0
Interlimb volume differencedetected via truncated cone method from circumference measurements
Day 0
between side differences of ultrasonographic dermal thickness measurements
Time Frame: Day 0
between side differences of ultrasonographic dermal thickness measurements
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2018

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

December 19, 2018

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators don't plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on ultrasonographic dermal thickness measurements

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe