Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema (ELOCS)
Primary Purpose
Lymphedema
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intensive decongestive treatment
Cellu M6
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring lymphedema, breast cancer
Eligibility Criteria
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.
Sites / Locations
- MALLOIZEL DELAUNAY Julie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
intensive decongestive treatment (IDT)
IDT + Cellu M6
Cellu M6 + bandages
Arm Description
Patients will receive an intensive decongestive treatment for 5 days
Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
Patients will receive an bandages + Cellu M6 for 5 days
Outcomes
Primary Outcome Measures
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
Secondary Outcome Measures
Progression of the excessive volume in the arm since hospitalization
assess adverse effects
Full Information
NCT ID
NCT02506530
First Posted
July 16, 2015
Last Updated
August 19, 2019
Sponsor
University Hospital, Toulouse
Collaborators
LPG SYSTEMS
1. Study Identification
Unique Protocol Identification Number
NCT02506530
Brief Title
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
Acronym
ELOCS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
LPG SYSTEMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
lymphedema, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intensive decongestive treatment (IDT)
Arm Type
Active Comparator
Arm Description
Patients will receive an intensive decongestive treatment for 5 days
Arm Title
IDT + Cellu M6
Arm Type
Experimental
Arm Description
Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
Arm Title
Cellu M6 + bandages
Arm Type
Active Comparator
Arm Description
Patients will receive an bandages + Cellu M6 for 5 days
Intervention Type
Procedure
Intervention Name(s)
intensive decongestive treatment
Intervention Description
intensive decongestive treatment
Intervention Type
Device
Intervention Name(s)
Cellu M6
Intervention Description
Use of Cellu M6
Primary Outcome Measure Information:
Title
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression of the excessive volume in the arm since hospitalization
Time Frame
6 months
Title
assess adverse effects
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
cost effectiveness analysis of treatments
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie MALLOIZEL-DELAUNAY, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
MALLOIZEL DELAUNAY Julie
City
Toulouse
State/Province
Midi Pyrenees
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19147865
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.
Results Reference
background
PubMed Identifier
19235573
Citation
Karki 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.
Results Reference
background
PubMed Identifier
19522678
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.
Results Reference
background
PubMed Identifier
16826318
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. doi: 10.1007/s10549-006-9297-6. Epub 2006 Jul 7.
Results Reference
background
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Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
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