Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
- Conditions
- Lymphedema of Upper Limb
- Interventions
- Device: Compressive bandagingDevice: MOBIDERM Autofit Armsleeve
- Registration Number
- NCT06264817
- Lead Sponsor
- Thuasne
- Brief Summary
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
- Detailed Description
The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.
The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.
In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Volume difference between affected and healthy arm ≥ 10%
- 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.
- Stage I lymphedema or located in several places.
- Patients for whom compression is contraindicated.
- Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- Pregnant or breastfeeding patient
- Patient intolerant to MOBIDERM Autofit or known allergies to the components used.
- Participation to any other clinical study which has an impact on the different endpoints
- Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group : compressive bandaging Compressive bandaging Control group : compressive bandaging: * Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice * Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night Intervention group: MOBIDERM Autofit Armsleeve MOBIDERM Autofit Armsleeve Intervention group: MOBIDERM Autofit Armsleeve * Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time) * Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night
- Primary Outcome Measures
Name Time Method Volume excess variation 8 weeks The primary endpoint of this study is to compare between both groups the volume evolution of the upper limb between inclusion and the end of the study. Limb Volume is calculated with truncated cone formula.
- Secondary Outcome Measures
Name Time Method Resource consumption 3 and 8 weeks Resource consumption is measured by the number and duration (per minute) of lymphedema-related healthcare consultations and hospitalizations.
Lymphedema related Quality of life (QoL) 3 and 8 weeks The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool is designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain is scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit
Doctors' opinion on improving the patient's health condition 3 and 8 weeks Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I 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 "
Patient's opinion on Global Impression of Change 3 and 8 weeks Patient's opinion on Global Impression of Change about her general condition is measured by the 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
Satisfaction about the device 8 weeks Patient's satisfaction with regards to MOBIDERM® Autofit vs bandages is measured by a satisfaction questionnaire. This questionnaire is focused on the product positioning with a question with 4 levels: very easy (better outcome), easy, difficult, very difficult (worse outcome) and the comfort with a question with 4 levels very comfortable (better outcome), comfortable, uncomfortable, very uncomfortable (worse outcome).
The safety 8 weeks Number and type of serious and non-serious Adverse Device Effects (ADE).
Compliance to treatment 8 weeks The compliance to treatment (day-time and night-time) 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 when the device is worn and the average wearing time
General quality of life (QoL) 3 and 8 weeks The evolution of QoL is measured by the EQ5D3L questionnaire completed by the patient. The EQ-5D3L questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems (Level 1 is coded as a '1'), moderate problems (Level 2 is coded as a '2'), and extreme problems (Level 3 is coded as a '3'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.Skin elasticity 3 and 8 weeks The evolution of skin thickness and elasticity is measured by ultrasound
Ttissue induration 3 and 8 weeks The evolution of tissue induration is measured via the skinfibrometer (Delfin Tech).
Trial Locations
- Locations (2)
ANKARA
🇹🇷Ankara, Turkey
Pinar BORMAN
🇹🇷Ankara, Turkey