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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 63
- 试验地点
- 9
- 主要终点
- The 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 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.
详细描述
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.
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 the 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
- •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
排除标准
- 未提供
结局指标
主要结局
The volume excess variation
时间窗: 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.
次要结局
- The quality of life (QoL): LYMQOL ARM self-questionnaire(30 and 90 days)
- The range of motion(30 and 90 days)
- Patient's opinion on Global Impression of Change (PGI-C)(30 and 90 days)
- Doctors' opinion on severity about the lymphedema (CGI-S)(30 and 90 days)
- The volume excess variation(30 days)
- number of days/nights : The compliance to treatment(30 and 90 days)
- The satisfaction about the daytime device: questionnaire(90 days)
- The quality of life (QoL): EQ-5D-5L self-questionnaire(30 and 90 days)
- The satisfaction about the device: questionnaire(90 days)
- Number and type of serious and non-serious Adverse Device Effects(90 days)
- The elastometry(30 and 90 days)
- The evolution of quality of sleep: Jenkins self-questionnaire(30 and 90 days)
- Doctors' opinion on improving the patient's health condition (Clinical Global Improvement Impression)(30 and 90 days)
- The percentage of patients presenting with a failure of maintenance(30 and 90 days)