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| Name | Class |
|---|---|
| LPG SYSTEMS | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive decongestive treatment (IDT) | Active Comparator | Patients will receive an intensive decongestive treatment for 5 days |
|
| IDT + Cellu M6 | Experimental | Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days |
|
| Cellu M6 + bandages | Active Comparator | Patients will receive an bandages + Cellu M6 for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive decongestive treatment | Procedure | intensive decongestive treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of the excessive volume in the arm since hospitalization | 6 months | |
| assess adverse effects | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| cost effectiveness analysis of treatments | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie MALLOIZEL-DELAUNAY, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MALLOIZEL DELAUNAY Julie | Toulouse | Midi Pyrenees | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31419694 | Result | Malloizel-Delaunay J, Chantalat E, Bongard V, Chaput B, Garmy-Susini B, Yannoutsos A, Vaysse C. Endermology treatment for breast cancer related lymphedema (ELOCS): Protocol for a phase II randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:35-41. doi: 10.1016/j.ejogrb.2019.07.040. Epub 2019 Aug 7. | |
| 38853038 |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Cellu M6 | Device | Use of Cellu M6 |
|
| Malloizel-Delaunay J, Weyl A, Brusq C, Chaput B, Garmy-Susini B, Bongard V, Vaysse C. New Strategy for Breast Cancer Related Lymphedema Treatment by Endermology: ELOCS Phase II Randomized Controlled Trial. Clin Breast Cancer. 2024 Aug;24(6):533-540. doi: 10.1016/j.clbc.2024.05.009. Epub 2024 May 22. |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |