Clinical trial NCT04203069: Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Arm
Keywords: Lymphedema of upper arm
Auto-Adjustable MOBIDERM® Autofit Armsleeve
Compression garments
Maintenance phase
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
First posted: 2019-12-18
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open-label RIPH 2 study multicenter, controlled, randomized, with two parallel groups.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Non-inclusion criteria :

* 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
* Vulnerable patient according to the article L.1121-6 of the French Public Health Code, the adults being the object of a legal protective measure or enable to express their consent according to the article L.1121-8 of French Public Health Code

Primary outcomes:
measure: The volume excess variation
timeFrame: 90 days
Secondary outcomes:
measure: The quality of life (QoL): LYMQOL ARM self-questionnaire
timeFrame: 30 and 90 days
measure: The range of motion
timeFrame: 30 and 90 days
measure: The volume excess variation
timeFrame: 30 days
measure: Patient's opinion on Global Impression of Change (PGI-C)
timeFrame: 30 and 90 days
measure: Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression)
timeFrame: 30 and 90 days
measure: Doctors' opinion on severity about the lymphedema (CGI-S)
timeFrame: 30 and 90 days
measure: number of days/nights : The compliance to treatment
timeFrame: 30 and 90 days
measure: The evolution of quality of sleep: Jenkins self-questionnaire
timeFrame: 30 and 90 days
measure: The satisfaction about the device: questionnaire
timeFrame: 90 days
measure: Number and type of serious and non-serious Adverse Device Effects
timeFrame: 90 days
measure: The elastometry
timeFrame: 30 and 90 days
measure: The percentage of patients presenting with a failure of maintenance
timeFrame: 30 and 90 days
measure: The satisfaction about the daytime device: questionnaire
timeFrame: 90 days
measure: The quality of life (QoL): EQ-5D-5L self-questionnaire
timeFrame: 30 and 90 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble
city: Montpellier
country: France
facility: Chu Montpellier
city: Mulhouse
country: France
facility: Ghr Mulhouse
city: Nice
country: France
facility: CHU NICE
city: Nîmes
country: France
facility: Nimes
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: CHRU Tours
city: Ankara
country: Turkey
facility: Turkey
Study officials:
affiliation: University Hospital, Montpellier
name: ISABELLE QUERE, PUPH,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.