Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase

NCT04203069 | Completed

• 2 other identifiers: EC29ANSM
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 8

Brief Summary

This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer. Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.

Conditions

Lymphedema of Upper Arm

Keywords

Lymphedema of upper arm; Auto-Adjustable MOBIDERM® Autofit Armsleeve; Compression garments; Maintenance phase

Outcome Measures

Primary Outcomes (1)

• The volume excess variation

  The primary endpoint of this study is to compare the volume excess variation of the upper limb between both groups from D0 to D90. Volume excess is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula.

  90 days

Secondary Outcomes (14)

• The quality of life (QoL): LYMQOL ARM self-questionnaire

  30 and 90 days

• The range of motion

  30 and 90 days

• The volume excess variation

  30 days

• Patient's opinion on Global Impression of Change (PGI-C)

  30 and 90 days

• Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression)

  30 and 90 days

Study Arms (2)

Control group : Day-time compression sleeve

PLACEBO COMPARATOR

Control group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) during 90 days.

Device: Control group : Day-time compression sleeve

Day-time compression sleeve and Night-time MOBIDERM Autofit

EXPERIMENTAL

Intervention group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) + night-time Auto-Adjustable MOBIDERM® Autofit Armsleeve device with the possibility to wear an additional MOBIDERM® glove if a patient has a finger edema during 90 days.

Device: Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit

Interventions

Control group : Day-time compression sleeve DEVICE

In the control group, patients wear only day-time compression garment : lymphatrex during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).

Control group : Day-time compression sleeve

Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit DEVICE

In the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).

Day-time compression sleeve and Night-time MOBIDERM Autofit

Eligibility Criteria

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

You may qualify if:

• Women responding positively to the lymphedema reduction phase defined by a ≥ 20% decrease in lymphedema volume at the end of DLT
• Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
• 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
• Affiliated to the General regime of the Social Security or covered by a similar health insurance system
• Stage I lymphedema or located in several places
• Active cellulitis / Infectious dermo-hypodermatitis
• Lymphedema associated with active cancer needing acute chemotherapy
• Motor and sensitive neurological deficiency / psychiatric or addictive disorders
• Post-operative edema (i.e acute edema occurring during the days following breast cancer-related surgery)
• Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis, presence of skin lesions on the armsleeve placement
• Pregnant or breastfeeding patient
• Previous history of hypersensitivity to MOBIDERM® technology or lymphatrex garment General conditions
• Participation to any other clinical study which has an impact on the different endpoints
• Unlikely to be followed up to 3 months with clinical assessment as per investigator's judgment

Sponsors & Collaborators

• Thuasne: lead
• International Clinical Trials Association: collaborator

Study Sites (8)

Chu Grenoble

Grenoble, France

Location

Chu Montpellier

Montpellier, France

Location

Ghr Mulhouse

Mulhouse, France

Location

CHU NICE

Nice, France

Location

Nimes

Nîmes, France

Location

Chu Toulouse

Toulouse, France

Location

CHRU Tours

Tours, 37044, France

Location

Turkey

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

  PMID: 24931830 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

• Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.

  PMID: 24013569 BACKGROUND

Study Officials

• ISABELLE QUERE, PUPH,MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

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 the patient's group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective open-label RIPH 2 study multicenter, controlled, randomized, with two parallel groups.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: July 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: September 15, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); FR (7)