Back to resultsLocal Compression Seroma DIminution Objective (CLODIS) (CLODIS)
Primary Purpose
Breast Cancer, Mastectomy, Seroma
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Compression by chest bandage urgo K2®
punctures
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing.
- Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
- Neo adjuvant chemotherapy authorized.
- Absence of known metastases.
- Patient has given written consent.
Exclusion Criteria:
- Mastectomy with immediate reconstruction.
- Partial mastectomy.
- Concurrent bilateral mastectomy.
- Delay in healing observed at inclusion.
- Patient under legal protection.
- Chronic respiratory failure.
- Patient with a pacemaker.
- Personality disorders and known progressive psychiatric pathology.
- Inability to submit to trial follow-up
Sites / Locations
- TANQUEREL JulieRecruiting
- Centre Françis BaclesseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compression by chest bandage urgo K2®
punctures
Arm Description
After the second puncture, the local compression by thoracic bandage will be put in place. The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out. During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit. The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
After the second puncture, the patient will be seen at the same frequency as in the experimental arm. The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.
Outcomes
Primary Outcome Measures
Number of puncture(s) after inclusion in both patient groups
In each group, we will count the number of punctures performed after the 2nd puncture with a volume > 250ml (inclusion).
Secondary Outcome Measures
The time required to take charge of adjuvant treatments
Deferral of adjuvant therapy related to seroma: Treatment regimen and adjuvant appointments will be collected at inclusion. Each deviation will be analyzed and attributed or not to the presence or complications of seroma.
Volume punctured after inclusion in both patient groups.
For each new puncture, the volume of serolymphatic fluid will be measured and the time between two punctures analyzed
comparison of the average change Quality of life scores between each arm
Quality of life is assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer (study inclusion and exit). The EORTC QLQ-C30 questionnaire, resulting in a score for the quality of life between 0 to 100.
comparison of the average change anxiety scores between each arm
Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale (study inclusion and exit)
comparison of the average change Pain scores between each arm
Numerical rating scale for pain (EN) The EN evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation", 3 "pain threshold", 10 "pain as bad as could be.(at each visit),
Neuropathic Pain (DN4) (inclusion and study exit)
The aesthetic impact on the puncture site.
The evaluation of the aesthetic impact on the puncture zone will be carried out by comparing the photographs taken at the inclusion, during the visit to the consultation at 10-15 days after the last puncture (for the standard arm) and at 10-15 days after the removal of the bandage device and finally during the consultation with the oncologist.
Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture
Based on the observation grids carried out by the 2 professionals during a separate evaluation, we compare the 4 items defined to the indication chosen for the puncture as well as the volume of puncture when it is carried out.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03598712
Brief Title
Local Compression Seroma DIminution Objective (CLODIS)
Acronym
CLODIS
Official Title
Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.
Detailed Description
The most common complication induced by mastectomy is seroma formation. This seroma is a serolymphatic effusion that is created in the days following surgery. Iterative puncture is the only treatment for seroma mentioned in the literature. A retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. The research hypothesis is that by applying local compression by chest bandaging with the Urgo® K2 kit, the "dead space" created by surgery would be removed. This would help resorb the seroma and reduce the number of punctures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Mastectomy, Seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3 prospective, randomized, monocentric controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression by chest bandage urgo K2®
Arm Type
Experimental
Arm Description
After the second puncture, the local compression by thoracic bandage will be put in place.
The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out.
During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit.
The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
Arm Title
punctures
Arm Type
Active Comparator
Arm Description
After the second puncture, the patient will be seen at the same frequency as in the experimental arm.
The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.
Intervention Type
Device
Intervention Name(s)
Compression by chest bandage urgo K2®
Intervention Description
- Installation of a short stretch belt (urgo K2® kit)
- Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit).
- Control of the pressure exerted by the bandage by the "KIKUHIME® Sub Bandge pressure Monitor" device
Intervention Type
Procedure
Intervention Name(s)
punctures
Intervention Description
Every 7 days after the second puncture of a volume > 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.
Primary Outcome Measure Information:
Title
Number of puncture(s) after inclusion in both patient groups
Description
In each group, we will count the number of punctures performed after the 2nd puncture with a volume > 250ml (inclusion).
Time Frame
180 days
Secondary Outcome Measure Information:
Title
The time required to take charge of adjuvant treatments
Description
Deferral of adjuvant therapy related to seroma: Treatment regimen and adjuvant appointments will be collected at inclusion. Each deviation will be analyzed and attributed or not to the presence or complications of seroma.
Time Frame
180 days
Title
Volume punctured after inclusion in both patient groups.
Description
For each new puncture, the volume of serolymphatic fluid will be measured and the time between two punctures analyzed
Time Frame
180 days
Title
comparison of the average change Quality of life scores between each arm
Description
Quality of life is assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer (study inclusion and exit). The EORTC QLQ-C30 questionnaire, resulting in a score for the quality of life between 0 to 100.
Time Frame
180 days
Title
comparison of the average change anxiety scores between each arm
Description
Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale (study inclusion and exit)
Time Frame
180 days
Title
comparison of the average change Pain scores between each arm
Description
Numerical rating scale for pain (EN) The EN evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation", 3 "pain threshold", 10 "pain as bad as could be.(at each visit),
Neuropathic Pain (DN4) (inclusion and study exit)
Time Frame
180 days
Title
The aesthetic impact on the puncture site.
Description
The evaluation of the aesthetic impact on the puncture zone will be carried out by comparing the photographs taken at the inclusion, during the visit to the consultation at 10-15 days after the last puncture (for the standard arm) and at 10-15 days after the removal of the bandage device and finally during the consultation with the oncologist.
Time Frame
180 days
Title
Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture
Description
Based on the observation grids carried out by the 2 professionals during a separate evaluation, we compare the 4 items defined to the indication chosen for the puncture as well as the volume of puncture when it is carried out.
Time Frame
180 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing.
Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
Neo adjuvant chemotherapy authorized.
Absence of known metastases.
Patient has given written consent.
Exclusion Criteria:
Mastectomy with immediate reconstruction.
Partial mastectomy.
Concurrent bilateral mastectomy.
Delay in healing observed at inclusion.
Patient under legal protection.
Chronic respiratory failure.
Patient with a pacemaker.
Personality disorders and known progressive psychiatric pathology.
Inability to submit to trial follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JULIE TANQUREL, NURSE
Phone
33231455631
Email
j.tanquerel@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
FRANCOIS GERNIER, PROJECT MANAGER
Phone
33231454043
Email
f.gernier@baclesse.unicancer.fr
Facility Information:
Facility Name
TANQUEREL Julie
City
Caen
ZIP/Postal Code
14400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JULIE TANQUEREL, NURSE
Phone
33 2 31 45 5631
Email
j.tanquerel@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
FRANCOIS GERNIER, PROJECT MANAGER
Phone
33 2 31 45 4043
Email
f.gernier@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
JEAN-FRANCOIS LEBRUN, MD
Facility Name
Centre Françis Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François LEBRUN, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Local Compression Seroma DIminution Objective (CLODIS)
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