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

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ClinicalTrials.gov Identifier: NCT04203069
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
International Clinical Trials Association
Information provided by (Responsible Party):
Thuasne

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.


Condition or disease Intervention/treatment Phase
Lymphedema of Upper Arm Device: Control group : Day-time compression sleeve Device: Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit Not Applicable

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.The sleeves are made of polyamide and elastane on the outside and adhesive non-woven fabric and polyethylene foam on the inside.

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. MOBIDERM® foam squares are smaller on the thumb than on the arm to facilitate limb mobility. The product is a ready-to-use garment made in 6 different sizes, 2 lengths, left/right arm according to the size grid.

The level of pressure is around 10-15mmHg. The patient will then be able to adjust the product more or less tightly in his everyday life.

The product is currently marketed in many countries and is reimbursed in the following countries: the Netherlands, UK, Scandinavia, Slovakia, Korea, Japan, Cz Republic in the indication of the treatment of lymphedema.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective open-label RIPH 2 study multicenter, controlled, randomized, with two parallel groups.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Placebo Comparator: Control group : Day-time compression sleeve
Control group : Patients will wear the Day-time compression sleeve : THUASNE lymphatrex (± mitten) during 90 days.
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).


Experimental: 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.
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).





Primary Outcome Measures :
  1. The volume excess variation [ Time Frame: 90 days ]
    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.


Secondary Outcome Measures :
  1. The quality of life (QoL): LYMQOL ARM self-questionnaire [ Time Frame: 30 and 90 days ]
    The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool was designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain was scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit.

  2. The range of motion [ Time Frame: 30 and 90 days ]
    The evolution of range of motion of the arm is measured by Constant score. This questionnaire is composed of 4 areas : active mobility, pain, current mobility, power. Active mobility is on 40 points, pain is on 15 points, current mobility is on 20 points, power is on 25 points. The total score is on 100 points (0 point = bad condition : non functional shoulder, 100 = good condition : functional shoulder)

  3. The volume excess variation [ Time Frame: 30 days ]
    Volume excess is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula.

  4. Patient's opinion on Global Impression of Change (PGI-C) [ Time Frame: 30 and 90 days ]
    Patient's opinion on Global Impression of Change about her general condition is measured by the modified PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference.

  5. Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression) [ Time Frame: 30 and 90 days ]
    Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I modified questionnaire (Clinical Global Improvement Impression). This questionnaire allows doctors to evaluate the improvement of patients. The scale has 7 levels from "very strongly improved"(better outcome) to "very strongly aggravated"(worse outcome).Intermediate levels are: " Significantly improved " ; " Slightly improved " ; " No improvement " ; " Slightly aggravated " ; " Seriously aggravated ".

  6. Doctors' opinion on severity about the lymphedema (CGI-S) [ Time Frame: 30 and 90 days ]
    Doctors' opinion on severity about the lymphedema is measured by CGI-S. This questionnaire assesses the severity of lymphedema. This scale has 7 levels from "normal, not sick at all" (better outcome) to " among the most severely ill patients "(worse outcome). Intermediate levels are: " borderline ill " ; " slightly ill " ; " moderately ill " ; " clearly ill " ; " severely ill ".

  7. number of days/nights : The compliance to treatment [ Time Frame: 30 and 90 days ]
    The compliance to treatment (day-time and night-time only for Intervention Group) is reported by the physician in the e-CRF according to the patient diary. The compliance is measured in number of days and or nights (groupe I) when the device was worn and the average wearing time was : Full day/night, >50% of the day/night,<50% of the day/night

  8. The evolution of quality of sleep: Jenkins self-questionnaire [ Time Frame: 30 and 90 days ]
    The evolution of quality of sleep is measured by Jenkins self-questionnaire. This scale is composed of four questions about the quality of sleep.

  9. The satisfaction about the device: questionnaire [ Time Frame: 90 days ]
    Patient's satisfaction with regards to MOBIDERM® Autofit for patients from intervention group only by a satisfaction questionnaire. This questionnaire is focused on the product positioning and the comfort.

  10. Number and type of serious and non-serious Adverse Device Effects [ Time Frame: 90 days ]
    Number and type of serious and non-serious Adverse Device Effects (ADE) with a focus on cutaneous ADE will be reported during the study.

  11. The elastometry [ Time Frame: 30 and 90 days ]
    To compare the evolution of skin thickness, elasticity, suppleness on a subgroup of patients by ultrasound.

  12. The percentage of patients presenting with a failure of maintenance [ Time Frame: 30 and 90 days ]
    Percentage of patients presenting with a failure of maintenance phase, defined by a volume increase ≥ 30% of the volume reduction observed during intensive phase of decongestive lymphedema therapy (DLT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women responding positively to the lymphedema reduction phase defined by a ≥ 30% 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203069


Contacts
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Contact: ISABELLE QUERE, PUPH, MD +33467337028 i-quere@chu-montpellier.fr
Contact: ASTRID PICOLET +33640392490 astrid.picolet@thuasne.fr

Locations
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France
Chu Montpellier Not yet recruiting
Montpellier, France
Principal Investigator: Isabelle QUERE, PUPH, MD         
Ghr Mulhouse Not yet recruiting
Mulhouse, France
Principal Investigator: Amer HAMADE, MD         
Chu Toulouse Recruiting
Toulouse, France
Principal Investigator: Julie MALLOIZEL, MD         
CHRU Tours Not yet recruiting
Tours, France, 37044
Sub-Investigator: Loic VAILLANT, PUPH,MD         
Principal Investigator: Valerie TAUVERON, MD         
Sponsors and Collaborators
Thuasne
International Clinical Trials Association
Investigators
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Principal Investigator: ISABELLE QUERE, PUPH,MD University Hospital, Montpellier
Publications:
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Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT04203069    
Other Study ID Numbers: EC29
ANSM ( Other Identifier: 2019-A02216-51 )
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thuasne:
Lymphedema of upper arm
Auto-Adjustable MOBIDERM® Autofit Armsleeve
Compression garments
Maintenance phase
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases