Lymphedema Clinical Trial
— ELOCSOfficial title:
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.
Verified date | August 2019 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
Status | Completed |
Enrollment | 93 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | MALLOIZEL DELAUNAY Julie | Toulouse | Midi Pyrenees |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse | LPG SYSTEMS |
France,
Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251. Review. — View Citation
Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001. Review. — View Citation
Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006. — View Citation
Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. Epub 2006 Jul 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | cost effectiveness analysis of treatments | 6 months | ||
Primary | The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%) | 6 months | ||
Secondary | Progression of the excessive volume in the arm since hospitalization | 6 months | ||
Secondary | assess adverse effects | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Completed |
NCT06067880 -
Surgical Intervention and Lymphatic Diseases.
|
||
Active, not recruiting |
NCT04797390 -
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT02676752 -
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
|
||
Completed |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
Recruiting |
NCT01318785 -
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
|
Phase 2 | |
Enrolling by invitation |
NCT02375165 -
Biomarkers for the Detection of Lymphatic Insufficiency
|
||
Completed |
NCT00852930 -
Low Level Laser Treatment and Breast Cancer Related Lymphedema
|
Phase 4 | |
Completed |
NCT01112189 -
Use of Stem Cells in Lymphedema Post Mastectomy
|
Phase 1/Phase 2 | |
Completed |
NCT02308488 -
Study of Prone Accelerated Breast And Nodal IMRT
|
N/A | |
Completed |
NCT00743314 -
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
|
Early Phase 1 | |
Recruiting |
NCT06237907 -
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
|
||
Terminated |
NCT01580800 -
National Breast Cancer and Lymphedema Registry
|
||
Suspended |
NCT05366699 -
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
|
N/A | |
Completed |
NCT06249360 -
Lymphatic System Reflux After Lymphatic Operation
|
||
Completed |
NCT06220903 -
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
|
N/A | |
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT06041958 -
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
|
N/A |