Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Official title

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)

Overview

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

Detailed description

The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.

The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.

Interventions

• Device 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
• Device 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

Primary outcome measures

• Volume excess variation [Time frame: 8 weeks]

Secondary outcome measures (12)

• Resource consumption [Time frame: 3 and 8 weeks]
• Resource consumption [Time frame: 3 and 8 weeks]
• Resource consumption [Time frame: 3 and 8 weeks]
• Lymphedema related Quality of life (QoL) [Time frame: 3 and 8 weeks]
• Doctors' opinion on improving the patient's health condition [Time frame: 3 and 8 weeks]
• Patient's opinion on Global Impression of Change [Time frame: 3 and 8 weeks]
• Satisfaction about the device [Time frame: 8 weeks]
• The safety [Time frame: 8 weeks]
• Compliance to treatment [Time frame: 8 weeks]
• General quality of life (QoL) [Time frame: 3 and 8 weeks]
• Skin elasticity [Time frame: 3 and 8 weeks]
• Ttissue induration [Time frame: 3 and 8 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 2 centers

• ANKARA — Ankara
• Pinar BORMAN — Ankara

Publications

• Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534. PMID 37106735
• Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9. PMID 28281052
• Borman P, Koyuncu EG, Yaman A, Calp E, Koc F, Sargut R, Karahan S. The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2021 Jun;19(3):286-294. doi: 10.1089/lrb.2020.0088. Epub 2020 Dec 2. PMID 33270499

Identifiers

NCT: NCT06264817 · EC 48 LyberT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗