Clinical trial NCT06009666: Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema
Official title: Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema of Upper Arm
Stiffness of Hand, Not Elsewhere Classified
Evaluations, Diagnostic Self
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In our study, individuals with breast cancer-related lymphedema diagnosis followed by Marmara University Pendik Training and Research Hospital Physical Medicine and Rehabilitation Department were included in the patient group, while upper extremity data of healthy volunteers without a known lymphedema history were controlled by one-to-one matching, considering the dominant and lymphedema sides of the patient group. included in the group.

Brief summary: The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Detailed description: Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Eligibility criteria: Inclusion Criteria:

For the patient group

* between the ages of 18-75
* diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
* being stage 0-1-2 lymphedema according to ISL staging For the control group
* between the ages of 18-75
* no history of breast cancer

Exclusion Criteria:

* History of surgery in the assessment area
* History of trauma at the assessment site
* Active infection in the assessment area
* Presence of congenital or acquired malformations at the assessment site
* Primary lymphedema
* those with any medical condition that may cause edema, such as advanced heart or kidney failure

Primary outcomes:
measure: B Mode Ultrasonography Measurements
timeFrame: Day 0
measure: Shear Wave Elastography Measurements
timeFrame: Day 0
measure: B Mode Ultrasonography Measurements
timeFrame: Day 0
Secondary outcomes:
measure: Association of USG and SWE Measurements With Symptoms
timeFrame: Day 0
measure: Association of USG and SWE Measurements With Functionality
timeFrame: Day 0
measure: Association of USG and SWE Measurements With Participation İn Daily Life
timeFrame: Day 0
measure: Association of USG and SWE Measurements With Volume Measurements
timeFrame: Day 0
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Canan Şanal-Toprak
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: CANAN ŞANAL TOPRAK
role: STUDY_CHAIR
References: