Health TrialsbyHealthPanel

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

ConditionLymphedema of Upper Limb
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThuasne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control group : compressive bandagingActive comparator 1 intervention
Group B: Intervention group: MOBIDERM Autofit ArmsleeveExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Resource consumption

Resource consumption is measured by time of transports (travel time in minutes).

Time frame
3 and 8 weeks
2

Resource consumption

Resource consumption is measured by number of used medical devices (number).

Time frame
3 and 8 weeks
3

Resource consumption

Resource consumption is measured by the number and duration (per minute) of lymphedema-related healthcare consultations and hospitalizations.

Time frame
3 and 8 weeks
4

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

Time frame
3 and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thuasne

Lead sponsor

Source ClinicalTrials.gov
Apply now