Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

Study Overview
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Brief Summary
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This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

Detailed Description
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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).

Official Title
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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.

Conditions
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Lymphedema

Intervention / Treatment
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* Procedure: intensive decongestive treatment
* Device: Cellu M6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intensive decongestive treatment (IDT)<br>Patients will receive an intensive decongestive treatment for 5 days | Procedure: intensive decongestive treatment<br>* intensive decongestive treatment<br>|
| Experimental: IDT + Cellu M6<br>Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days | Procedure: intensive decongestive treatment<br>* intensive decongestive treatment<br>Device: Cellu M6<br>* Use of Cellu M6<br>|
| Active Comparator: Cellu M6 + bandages<br>Patients will receive an bandages + Cellu M6 for 5 days | Device: Cellu M6<br>* Use of Cellu M6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of the excessive volume in the arm since hospitalization |  | 6 months | 
| assess adverse effects |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, breast cancer