Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema (NCT07086053) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema
20 participantsStarted 2025-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intra- and Inter-Rater Reliability of MyotonPRO Measurements
Timeframe: Within 1 day
2
Intra- and Inter-Rater Reliability of MyotonPRO Measurements