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

NCT06264817 | Recruiting

• 1 other identifier: EC 48 LyberT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema of upper limb; Compression garments; lymphedema management

Outcome Measures

Primary Outcomes (1)

• Volume excess variation

  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.

  8 weeks

Secondary Outcomes (12)

• Resource consumption

  3 and 8 weeks

• Resource consumption

  3 and 8 weeks

• Resource consumption

  3 and 8 weeks

• Lymphedema related Quality of life (QoL)

  3 and 8 weeks

• Doctors' opinion on improving the patient's health condition

  3 and 8 weeks

Study Arms (2)

Control group : compressive bandaging

ACTIVE COMPARATOR

Control group : compressive bandaging: * Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice * Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night

Device: Compressive bandaging

Intervention group: MOBIDERM Autofit Armsleeve

EXPERIMENTAL

Intervention group: MOBIDERM Autofit Armsleeve * Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time) * Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night

Device: MOBIDERM Autofit Armsleeve

Interventions

MOBIDERM Autofit Armsleeve DEVICE

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

Intervention group: MOBIDERM Autofit Armsleeve

Compressive bandaging DEVICE

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

Control group : compressive bandaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (2)

ANKARA

Ankara, Turkey (Türkiye)

RECRUITING

Pinar BORMAN

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Burcu DUYUR ÇAKIT

  Ankara Training and Research Hospital Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu DUYUR ÇAKIT, MD

CONTACT

0533 654 24 55; burcudcakit@gmail.com

ASTRID PICOLET

CONTACT

0640392490; astrid.picolet@thuasne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, interventional, controlled-randomized, single blinded study

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: March 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: April 15, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)