Clinical trial NCT06264817: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema of Upper Limb
Keywords: Lymphedema of upper limb
Compression garments
lymphedema management
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, interventional, controlled-randomized, single blinded study
Primary purpose: TREATMENT

Brief 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

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.

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.

Primary outcomes:
measure: Volume excess variation
timeFrame: 8 weeks
Secondary outcomes:
measure: Resource consumption
timeFrame: 3 and 8 weeks
measure: Resource consumption
timeFrame: 3 and 8 weeks
measure: Resource consumption
timeFrame: 3 and 8 weeks
measure: Lymphedema related Quality of life (QoL)
timeFrame: 3 and 8 weeks
measure: Doctors' opinion on improving the patient's health condition
timeFrame: 3 and 8 weeks
measure: Patient's opinion on Global Impression of Change
timeFrame: 3 and 8 weeks
measure: Satisfaction about the device
timeFrame: 8 weeks
measure: The safety
timeFrame: 8 weeks
measure: Compliance to treatment
timeFrame: 8 weeks
measure: General quality of life (QoL)
timeFrame: 3 and 8 weeks
measure: Skin elasticity
timeFrame: 3 and 8 weeks
measure: Ttissue induration
timeFrame: 3 and 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: ANKARA
city: Ankara
country: Turkey
facility: Pinar BORMAN
Study officials:
affiliation: Ankara Training and Research Hospital Turkey
name: Burcu DUYUR ÇAKIT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.