Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema

NCT04213001 | Completed

• 1 other identifier: DokuzEUBanuNihan
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity.Early and accurate diagnosis of lymphedema is very important for effective treatment. In routine clinical practice there are various methods used to diagnose lymphedema such as history, physical examination and limb circumference. Circumferential measurement is based on the principle of circumference measurement at certain intervals (such as 4 cm, 5 cm, 10 cm) from certain anatomical reference points on the extremities. Volume calculation can also be made from a data obtained from circumferential measurements via a computer program. Circumferential and volume measurements are used in the diagnosis, severity of lymphedema and follow-up of treatment. Although it is the most commonly used method in practice, circumferential measurements and volume measurements alone can ignore changes in tissue structure and significant changes in the presence of latent lymphedema. At the same time, circumferential measurements are made at regular intervals and the difference between the healthy side and 2 cm or more is considered as lymphedema, which may neglect tissue and edema changes in areas not in the measuring area. Ultrasonography, which has been used in the measurement and evaluation of lymphedema in recent years, is a noninvasive economic method. Skin and subcutaneous distance in lymphedema can be measured by ultrasonography, and changes in tissue structure, fibrous tissue, adipose tissue and muscle tissue can be demonstrated. Fibrotic changes in lymphedema tissue play a key role in progression. Subcutaneous ultrasound echogenicity (SEG), which is thought to be a measure of lymphedema severity in extremities, was determined as stages 0, 1 and 2. According to this; Stage 0: No increase in echogenicity in the subcutaneous layer. That is, the subcutaneous fat layer is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-focused echogenic lines caused by bundles of connective tissue may be seen. In this study, the investigators aimed to determine the correlation between circumferential measurements and skin and subcutaneous tissue ultrasonography in breast cancer-related lymphedema patients.The primer aim of this study is to investigate the correlation between circumferential measurements and ultrasonographic measurements in breast cancer-related lymphedema. The secondary aim is to investigate the relationship among the changes in subcutaneous tissue structure (subcutaneous ultrasound echogenicity degree-SEG) and lymphedema severity in breast cancer-related lymphedema.

Conditions

Lymphedema of Upper Arm

Keywords

Lymphedema; Circumferential measurements; ultrasonography

Outcome Measures

Primary Outcomes (1)

• ultrasonographic measurement

  \- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement

  baseline

Study Arms (1)

measure

OTHER

circumference measure, ultrasonographic measure

Diagnostic Test: ultrasonographic measurement

Interventions

ultrasonographic measurement DIAGNOSTIC_TEST

ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement

measure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be diagnosed with breast cancer-related unilateral lymphedema
• Being over 18 years old
• Having a female gender

You may not qualify if:

• Bilateral breast cancer
• Existing upper extremity infection
• Lymphangitis
• Refusal to participate in the study
• Presence of edema in lower extremity

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz eylul university

Izmir, Inciralti, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• Erdinc Gunduz N, Dilek B, Sahin E, Ellidokuz H, Akalin E. Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2021 Dec;19(6):517-523. doi: 10.1089/lrb.2020.0068. Epub 2021 Feb 18.

  PMID: 33601960 DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Banu Dilek

  Dokuz Eylul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 30, 2019
• Study Start: January 2, 2020
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)