Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema (MARILYN)

THUASNE

Status: Completed

Conditions: Lymphedema

Treatments: Device: Auto-Adjustable MOBIDERM Armsleeve

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253186

2014-A01008-39

Details and patient eligibility

About

The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
• Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
• Lymphoedema with evident pitting sign (assessed as ++ or +++)
• Requiring compression therapy for, at least, the next 3 months.
• Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
• Signed informed consent prior to any study-mandated procedure.
• Not under any administrative or legal supervision.
• Covered by a health insurance system

Exclusion criteria

• Stage I lymphoedema
• Active cellulitis
• Lymphoedema associated with active cancer needing acute chemotherapy
• Motor and sensitive neurological deficiency
• Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
• Patient participating in any other clinical study
• Unlikely to be followed up to 3 months with clinical assessment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Group I

Experimental group

Description:

Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

Treatment:

Device: Auto-Adjustable MOBIDERM Armsleeve

Group II

No Intervention group

Description:

Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.