A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Thuasne
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Volume excess variation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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 patient's group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group : 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
干预措施: Compressive bandaging (Device)
Intervention group: 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
干预措施: MOBIDERM Autofit Armsleeve (Device)
结局指标
主要结局
Volume excess variation
时间窗: 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.
次要结局
- Lymphedema related Quality of life (QoL)(3 and 8 weeks)
- Doctors' opinion on improving the patient's health condition(3 and 8 weeks)
- Patient's opinion on Global Impression of Change(3 and 8 weeks)
- Satisfaction about the device(8 weeks)
- The safety(8 weeks)
- Compliance to treatment(8 weeks)
- General quality of life (QoL)(3 and 8 weeks)
- Skin elasticity(3 and 8 weeks)
- Ttissue induration(3 and 8 weeks)
- Resource consumption(3 and 8 weeks)