Using a new adjustable armsleeve to manage upper limb lymphedema
A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)
This study is testing a new adjustable armsleeve to see if it can help people with lymphedema from breast cancer manage swelling better than traditional compression bandages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thuasne Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Ankara and 1 other locations) |
| Trial ID | NCT06264817 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Auto-Adjustable MOBIDERM® Autofit Armsleeve in reducing upper limb volume excess in patients suffering from lymphedema related to breast cancer. The research compares this innovative armsleeve to traditional compression bandages, which can be cumbersome and uncomfortable for long-term use. By utilizing a device that adjusts to changes in limb volume, the study aims to improve patient compliance and overall quality of life. Participants will be monitored for changes in limb volume and comfort levels throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral secondary upper limb lymphedema of stage II or III following breast cancer treatment.
Not a fit: Patients with stage I lymphedema, those for whom compression is contraindicated, or individuals with active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the management of upper limb lymphedema, leading to better patient outcomes and improved quality of life.
How similar studies have performed: While traditional bandaging has been the standard, this study explores a novel approach with adjustable armsleeves, which has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer * Volume difference between affected and healthy arm ≥ 10% * Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided. * Signed informed consent prior to any study-mandated procedure. Exclusion Criteria: * Stage I lymphedema or located in several places. * Patients for whom compression is contraindicated. * Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis. * Motor and sensitive neurological deficiency / psychiatric or addictive disorders * Pregnant or breastfeeding patient * Patient intolerant to MOBIDERM Autofit or known allergies to the components used. * Participation to any other clinical study which has an impact on the different endpoints * Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
Where this trial is running
Ankara and 1 other locations
- Ankara — Ankara, Turkey (Türkiye) (Recruiting)
- Pinar BORMAN — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Burcu DUYUR ÇAKIT — Ankara Training and Research Hospital Turkey
- Study coordinator: Burcu DUYUR ÇAKIT, MD
- Email: burcudcakit@gmail.com
- Phone: 0533 654 24 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.