NCT04213001

Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema

Completed NA Last updated 21 May 2020

What this trial tests

NA trial testing ultrasonographic measurement in Lymphedema of Upper Arm in 34 participants. Completed in 31 January 2020.

Timeline

2 January 2020

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	Dokuz Eylul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	34
Start date	2 January 2020
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• ultrasonographic measurement

Conditions studied

• Lymphedema of Upper Arm — all drugs for Lymphedema of Upper Arm →

Sponsor

Dokuz Eylul University

Who can join

Adults 18 to 85, female only, with Lymphedema of Upper Arm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema.
   Erdinç Gündüz N, Dilek B, Şahin E, Ellidokuz H, et al · · 2021 · cited 6× · PMID 33601960 · DOI 10.1089/lrb.2020.0068