Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
研究概览
简要总结
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
详细描述
The main objective of the study is to assess the proportion of successfully treated patients (success rate).
That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :
Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).
Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days
Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).
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
- None
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
- •Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
- •Patients suffering from Lymphoedema for 6 months or more
- •Patients with a difference between arms >10%
- •Patients who had ever had an axillary node dissection
- •Patients hospitalized for intensive standard treatment.
排除标准
- •Primary lymphoedema
- •Venous insufficiency of the upper members
- •severe arterial obstruction
- •obliterating arteritis of the upper limbs
- •Bilateral lymphoedema
- •Breast cancer recurrence
- •Another cancer in treatment
- •Decompensated heart failure
- •Pacemaker
- •acute infection
- •Deep venous thrombosis
- •Skin atrophy of the upper member
- •Bullous dermatosis
- •Acute dermatitis with epidermitis or dermatitis-hypodermitis
- •Infected wound
- •Inflammatory scar or consequence of a recent surgery (<1 month)
- •Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat
- •Hyperalgesia of the shoulder
- •Pregnancy.
研究组 & 干预措施
intensive decongestive treatment (IDT)
Patients will receive an intensive decongestive treatment for 5 days
干预措施: intensive decongestive treatment (Procedure)
IDT + Cellu M6
Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
干预措施: intensive decongestive treatment (Procedure)
IDT + Cellu M6
Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
干预措施: Cellu M6 (Device)
Cellu M6 + bandages
Patients will receive an bandages + Cellu M6 for 5 days
干预措施: Cellu M6 (Device)
结局指标
主要结局
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
时间窗: 6 months
次要结局
- assess adverse effects(6 months)
- Progression of the excessive volume in the arm since hospitalization(6 months)