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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Lymphedema of Upper Limb
• Intervention / Treatment: Device: Compressive bandaging; Device: MOBIDERM Autofit Armsleeve

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burcu DUYUR ÇAKIT, MD; Phone Number: 0533 654 24 55; Email: burcudcakit@gmail.com
• Study Contact Backup: Name: ASTRID PICOLET; Phone Number: 0640392490; Email: astrid.picolet@thuasne.fr

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara
    • Contact: Burcu DUYUR ÇAKIT
  • Ankara, Turkey
    • Recruiting
    • Pinar BORMAN
    • Contact: Pinar BORMAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group : compressive bandaging; 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; 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
Experimental: Intervention group: MOBIDERM Autofit Armsleeve; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource consumption	Resource consumption is measured by time of transports (travel time in minutes).	3 and 8 weeks
Resource consumption	Resource consumption is measured by number of used medical devices (number).	3 and 8 weeks
Resource consumption	Resource consumption is measured by the number and duration (per minute) of lymphedema-related healthcare consultations and hospitalizations.	3 and 8 weeks
Lymphedema related Quality of life (QoL)	The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool is designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain is scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit	3 and 8 weeks
Doctors' opinion on improving the patient's health condition	Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I questionnaire (Clinical Global Improvement Impression). This questionnaire allows doctors to evaluate the improvement of patients. The scale has 7 levels from "very strongly improved"(better outcome) to "very strongly aggravated"(worse outcome).Intermediate levels are: " Significantly improved " ; " Slightly improved " ; " No improvement " ; " Slightly aggravated " ; " Seriously aggravated "	3 and 8 weeks
Patient's opinion on Global Impression of Change	Patient's opinion on Global Impression of Change about her general condition is measured by the PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference	3 and 8 weeks
Satisfaction about the device	Patient's satisfaction with regards to MOBIDERM® Autofit vs bandages is measured by a satisfaction questionnaire. This questionnaire is focused on the product positioning with a question with 4 levels: very easy (better outcome), easy, difficult, very difficult (worse outcome) and the comfort with a question with 4 levels very comfortable (better outcome), comfortable, uncomfortable, very uncomfortable (worse outcome).	8 weeks
The safety	Number and type of serious and non-serious Adverse Device Effects (ADE).	8 weeks
Compliance to treatment	The compliance to treatment (day-time and night-time) is reported by the physician in the e-CRF according to the patient diary. The compliance is measured in number of days and or nights when the device is worn and the average wearing time	8 weeks
General quality of life (QoL)	The evolution of QoL is measured by the EQ5D3L questionnaire completed by the patient. The EQ-5D3L questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems (Level 1 is coded as a '1'), moderate problems (Level 2 is coded as a '2'), and extreme problems (Level 3 is coded as a '3'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.	3 and 8 weeks
Ttissue induration	The evolution of tissue induration is measured via the skinfibrometer (Delfin Tech).	3 and 8 weeks
Skin elasticity	The evolution of skin thickness and elasticity is measured by ultrasound	3 and 8 weeks

Collaborators and Investigators

• Sponsor: Thuasne
• Investigators: Principal Investigator: Burcu DUYUR ÇAKIT, Ankara Training and Research Hospital Turkey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Compression garments; Lymphedema of upper limb; lymphedema management
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: EC 48 LyberT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No