NCT04203069

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

Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Thuasne · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The gold standard treatment to achieve volume reduction of lymphedema is based on a Decongestive Lymphedema Therapy (DLT).that consists in 2 consecutive phases: the initial intensive phase which aim is to obtain maximal reduction of lymphedema volume and a second, the maintenance phase which aim is to maintain the initial volumetric reduction achieved during phase 1 as long as possible. The second maintenance phase mostly based on patient self-management of his treatment, is not strictly codified, but includes compression therapy, nutritional recommendations, skin cares, physical exercises and manual lymphatic drainage. 24 hours compression using garments or bandages seems to be crucial for long term management of lymphedema. Garment and bandages prescriptions for daily treatment are a common practice in the maintenance phase but are often unsuitable for night treatment, as bandages are effective when well applied but are highly dependent on the patients' skills, and garments, due to their nature, can be poorly tolerated leading to low adherence from patients to self-management care. In the end, there is an unmet medical need for night treatment during maintenance phase. . In this context THUASNE developed a specific night-time garment, for lymphedema maintenance phase. It is a standard Auto-Adjustable Armsleeve using the MOBIDERM® technology. MOBIDERM® AUTOFIT is a standard self-adjusting compressive MOBIDERM® sleeve, with mitten. Several small rigid straps are placed throughout the product to facilitate the passage of the arm, to adapt the garment to the morphology of each patient and to tighten it. A first pilot randomized controlled study demonstrated some benefit to use MOBIDERM Autofit during night-time as an adjuvant treatment to daily compressive garment. The objective of this new study is to confirm, using a more robust methodology, the effect of Auto-Adjustable MOBIDERM® Autofit Armsleeve on maintenance phase treatment, worn during the night, within the period at risk for the so called rebound effect as reported in several observational studies.

Conditions

• Lymphedema of Upper Arm

Interventions

Type	Name	Description
DEVICE	Control group : Day-time compression sleeve	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).
DEVICE	Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit	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).

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-12-30
• Completion: 2024-09-15
• First posted: 2019-12-18
• Last updated: 2024-09-23

Locations

8 sites across 2 countries: France, Turkey (Türkiye)