MOBIDERM Autofit Armsleeve: In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks.
During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks
Compressive bandaging: In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks.
During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks
Study summary
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Volume excess variation — 8 weeks The primary endpoint of this study is to compare between both groups the volume evolution of the upper limb between inclusion and the end of the study. Limb Volume is calculated with truncated cone formula.
Trial sites (2)
Facility
City
Region
Status
ANKARA
Ankara
Turkey (Türkiye)
Recruiting
Pinar BORMAN
Ankara
Turkey (Türkiye)
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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