Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MOBIDERM Autofit Armsleeve, Self-bandages.
- Who it may be relevant to
- Registry conditions: Limb Lymphoedema. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cross-over, Randomized, Open Label Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
Overview
The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.
Detailed description
In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology, named MOBIDERM Autofit.
The device has already been evaluated in several clinical studies as an adjuvant treatment to daily compressive garment during night-time maintenance phase in women with Breast cancer related lymphedema.
The possibility to use this category of devices during both phases of lymphedema treatment has been reinforced recently by studies that showed a similar reduction in lymphedema volume with wraps versus conventional multilayer bandages \[Ochalek et al., 2023,Borman et al., 2021\].
The global objective of the MOBISCAN study is to reinforce the efficacy of MOBIDERM Autofit garment by assessing its efficacy and pressure maintenance versus bandages in the management of upper limb Lymphedema in night-time maintenance phase.
Interventions
- Device MOBIDERM Autofit Armsleeve
The MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month. - Device Self-bandages
Self-bandages will be worn by the patients at night for one month.
Primary outcome measures
- Volume excess variation [Time frame: 2 months (Inclusion, first month and second month visit)]
Secondary outcome measures (6)
- Evolution of affected upper limb volume: [Time frame: 2 months (Inclusion, first month and second month visit)]
- Device pressure: [Time frame: 2 months (Inclusion, first month and second month visit)]
- Evolution of hand lymphedema: [Time frame: 2 months (Inclusion, first month and second month visit)]
- Comfort / Ease of use / satisfaction: [Time frame: 2 month visit]
- Compliance: [Time frame: 2 months]
- Patient's safety [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Patient in maintenance phase of lymphedema treatment
- Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
- Signed informed consent prior to any study-mandated procedure.
Exclusion criteria
- Active cellulitis / Infectious dermo-hypodermatitis
- Lymphedema associated with active cancer needing acute chemotherapy
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
- Pregnant or breastfeeding patient
- 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
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Ödemzentrum Bad Berleburg Klinik — Bad Berleburg
Publications
- Cancer Information Sytem. https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ (September 2023, date last accessed).
Identifiers
NCT: NCT07355959 · EC55_MOBISCAN