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Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema

Primary Purpose

Lymphedema of Upper Arm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasonographic measurement
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphedema of Upper Arm focused on measuring Lymphedema, Circumferential measurements, ultrasonography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. To be diagnosed with breast cancer-related unilateral lymphedema
  2. Being over 18 years old
  3. Having a female gender

Exclusion Criteria:

  1. Bilateral breast cancer
  2. Existing upper extremity infection
  3. Lymphangitis
  4. Refusal to participate in the study
  5. Presence of edema in lower extremity

Sites / Locations

  • Dokuz eylul university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

measure

Arm Description

circumference measure, ultrasonographic measure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 24, 2019
Last Updated
May 20, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04213001
Brief Title
Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
Official Title
Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Patients with unilateral breast cancer-related lymphedema will be included in the study. The circumferences will be measured with a measuring tape from wrist ulnar styloid to axilla at 4 cm intervals. The point where the difference between the upper extremities was highest and the control point with no difference in the lower extremities will be marked. Ultrasonographic skin and subcutaneous thickness measurements will be performed from 4 quadrants; volar medial-lateral and dorsal medial-lateral sides of the extremity, with the probe placed transverse and perpendicular to the skin at the marked points. The severity of lymphedema was graded ultrasonographically according to the SEG scale. (Stage 0: No increase in echogenicity in the subcutaneous layer. That is, subcutaneous fat is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-oriented echogenic lines caused by bundles of connective tissue can be seen. Stage 2: A widespread increase in echogenicity echogenic lines cannot be identified.) Spearman test was used for correlations and Receiver Operating Characteristics (ROC) curve analysis was used to estimate the diagnostic accuracy. Sensitivity and specificity were calculated using a statistically significant threshold. Differences between ultrasonographic measurements between control points in lower extremities were compared with Wilcoxon test. The minimum number of patients to be included in the study, according to the G-Power program, effect size d = 0.5, alpha-α = 0.05 and power 0.80 was calculated to be at least 34.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Arm
Keywords
Lymphedema, Circumferential measurements, ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
measure
Arm Type
Other
Arm Description
circumference measure, ultrasonographic measure
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasonographic measurement
Intervention Description
ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
Primary Outcome Measure Information:
Title
ultrasonographic measurement
Description
- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be diagnosed with breast cancer-related unilateral lymphedema Being over 18 years old Having a female gender Exclusion Criteria: Bilateral breast cancer Existing upper extremity infection Lymphangitis Refusal to participate in the study Presence of edema in lower extremity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Dilek
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz eylul university
City
İzmir
State/Province
Inciralti
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33601960
Citation
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.
Results Reference
derived

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Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema

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