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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06264817

Lymphedema of Upper Limb

RECRUITING NA

Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects

NCT02187289

Breast Cancer Lymphedema

COMPLETED NA

Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study

NCT04787029

Breast Cancer Lymphedema

RECRUITING NA

Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema

NCT04934098

Breast Cancer Related Lymphedema Lymphedema, Secondary Lymphedema of Upper Arm +1 more

COMPLETED NA

Night-time Compression Systems for Breast Cancer Related Lymphedema

NCT01550250

Breast Neoplasms Lymphedema

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphedema of Upper Arm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group : Day-time compression sleeve

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

Group Type PLACEBO_COMPARATOR

Control group : Day-time compression sleeve

Intervention Type 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).

Day-time compression sleeve and Night-time MOBIDERM Autofit

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.

Group Type EXPERIMENTAL

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

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No