Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02506530
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2015-07-16
Brief Title:
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELOCS
Brief Summary:
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None