Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema (MYOLYMPH)

Kahramanmaraş Sütçü İmam University (KSU)

Status: Not yet enrolling

Conditions: Breast Cancer-Related Lymphedema

Treatments: Device: MyotonPRO

Study type: Interventional

Funder types: Other

Identifiers

NCT07086053

FSM-MYOTON-2025-01

Details and patient eligibility

About

This study aims to evaluate the intra- and inter-rater reliability of the MyotonPRO, a handheld device that measures the viscoelastic properties of the skin, in patients with breast cancer-related lymphedema. Twenty women with unilateral upper extremity lymphedema will be included. Each participant will undergo repeated skin assessments using the MyotonPRO by two independent raters. Additionally, ultrasonographic tissue characteristics and limb volume measurements will be performed. The findings are expected to contribute to the validation of the MyotonPRO for use in clinical lymphedema evaluation.

Full description

The study will be conducted at a single center with 20 women diagnosed with unilateral upper extremity lymphedema after mastectomy. Participants will be evaluated using the MyotonPRO device by two trained raters to assess intra- and inter-rater reliability. Ultrasonographic grading of subcutaneous echogenicity and echo-free space, as well as circumference and volume measurements, will be conducted to explore correlations with biomechanical tissue properties. Statistical analysis will include intraclass correlation coefficient (ICC) for reliability and Pearson correlation for validity. This study is expected to support the clinical use of MyotonPRO in lymphedema assessment.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants aged 18-80 years
• Unilateral upper extremity lymphedema secondary to breast cancer surgery
• Diagnosed with lymphedema at International Society of Lymphology (ISL) Stage 0, I, II, or III
• Willing and able to provide informed consent

Exclusion criteria

• Bilateral upper extremity lymphedema
• Cognitive or mental disorders that interfere with cooperation
• Neurological diseases
• Active infection
• Scleroderma or other skin disorders affecting elasticity
• Significant cardiac conditions that may interfere with assessment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Lymphedema Assessment Group

Experimental group

Description:

Patients with breast cancer-related lymphedema will undergo MyotonPRO and ultrasound measurements by two blinded raters to evaluate intra- and inter-rater reliability. No therapeutic intervention will be performed.

Treatment:

Device: MyotonPRO