Clinical trial · Interventional
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
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.
NCT02506530CI-TRIAL-00113099ELOCScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellu M6 | Device | — | UNRESOLVED |
| intensive decongestive treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- intensive decongestive treatment (IDT)
- description
- Patients will receive an intensive decongestive treatment for 5 days
- interventionNames
- Procedure: intensive decongestive treatment
- type
- EXPERIMENTAL
- label
- IDT + Cellu M6
- description
- Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
- interventionNames
- Procedure: intensive decongestive treatment
- Device: Cellu M6
- type
- ACTIVE_COMPARATOR
- label
- Cellu M6 + bandages
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTMalloizel-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. PMID 31419694
- RESULTMalloizel-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. PMID 38853038