This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
intensive decongestive treatment
Use of Cellu M6
MALLOIZEL DELAUNAY Julie
Toulouse, Midi Pyrenees, France
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
Time frame: 6 months
Progression of the excessive volume in the arm since hospitalization
Time frame: 6 months
assess adverse effects
Time frame: 6 months
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