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Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema (MARILYN)

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auto-Adjustable MOBIDERM Armsleeve
Sponsored by
Thuasne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
  • Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
  • Lymphoedema with evident pitting sign (assessed as ++ or +++)
  • Requiring compression therapy for, at least, the next 3 months.
  • Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
  • Signed informed consent prior to any study-mandated procedure.
  • Not under any administrative or legal supervision.
  • Covered by a health insurance system

Exclusion Criteria:

  • Stage I lymphoedema
  • Active cellulitis
  • Lymphoedema associated with active cancer needing acute chemotherapy
  • Motor and sensitive neurological deficiency
  • Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
  • Patient participating in any other clinical study
  • Unlikely to be followed up to 3 months with clinical assessment

Sites / Locations

  • CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group I

Group II

Arm Description

Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

Outcomes

Primary Outcome Measures

Change in excess arm volume
Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula

Secondary Outcome Measures

Full Information

First Posted
September 24, 2014
Last Updated
December 4, 2015
Sponsor
Thuasne
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1. Study Identification

Unique Protocol Identification Number
NCT02253186
Brief Title
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
Acronym
MARILYN
Official Title
Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
Arm Title
Group II
Arm Type
No Intervention
Arm Description
Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
Intervention Type
Device
Intervention Name(s)
Auto-Adjustable MOBIDERM Armsleeve
Other Intervention Name(s)
MOBIDERM Autofit
Primary Outcome Measure Information:
Title
Change in excess arm volume
Description
Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula
Time Frame
between Day 0 and Day 30

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization Lymphoedema with evident pitting sign (assessed as ++ or +++) Requiring compression therapy for, at least, the next 3 months. Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided. Signed informed consent prior to any study-mandated procedure. Not under any administrative or legal supervision. Covered by a health insurance system Exclusion Criteria: Stage I lymphoedema Active cellulitis Lymphoedema associated with active cancer needing acute chemotherapy Motor and sensitive neurological deficiency Post-operative oedema (i.e acute oedema following breast cancer-related surgery) Patient participating in any other clinical study Unlikely to be followed up to 3 months with clinical assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Quere, Prof
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema

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