Back to resultsFunctional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer. (BREAST)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery for unilateral breast reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast, Latissimus dorsi flap
Eligibility Criteria
Inclusion Criteria:
- Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
- Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
- Age between 18 and 80 years old
- Signature of free and informed consent
Exclusion Criteria:
- Patient with metastasis or disease progression
- Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
- Patient with a poor understanding of the French language
- Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
- Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
- Patient with a history of contralateral MR (all techniques combined)
- Patient with a history of contralateral breast cancer
- Patient does not have internet access to be able to connect to the "Exolis" software
Sites / Locations
- Centre Georges-François LeclercRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery for unilateral breast reconstruction
Arm Description
Patients treated in oncological surgery at the Center Georges-François Leclerc (CGFL) in Dijon for unilateral breast reconstruction after therapeutic total mastectomy. Before the surgery, 2 questionnaires will be completed by patients : BREAST-Q and DASH. Also, the isokinetic test and EMG will be performed. After the surgery, 2 questionnaires will be completed at one month, 3 months and 6 months. The Two tests will be performed at 3 moths and 6 months after the surgery.
Outcomes
Primary Outcome Measures
Measurement of the muscular moment
Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction
Secondary Outcome Measures
Evaluation of muscle moments
Evaluation of muscle moments, isokinetic measurements, performed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi (measurements before surgery, at 3 and 6 months)
Comparison of muscular moments
Comparison of muscular moments on the operated and "healthy" sides at 3 months and 6 months. Perfomed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi
Calculation of adduction deficit
Calculation of adduction deficit is defined as a relative difference of more than 5% compared to the measurement taken preoperatively. Patients who completed at least one physiotherapy session post-surgery and before 3 months will be compared to the others.
Measurement of surface electromyographic activity
Measurement of surface electromyographic activity (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months and 6 months post-surgery
Functional clinical impact and quality of life
Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery.
The DASH self-questionnaire is an upper limb function assessment scale. It offers the ability to perform 23 activities, the severity of the symptoms and optional sports or instrumental and professional activity.
Functional clinical impact and quality of life
Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery.
The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction.
Full Information
NCT ID
NCT05278741
First Posted
January 28, 2022
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT05278741
Brief Title
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
Acronym
BREAST
Official Title
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
May 25, 2025 (Anticipated)
Study Completion Date
May 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap.
The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months and 6 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast, Latissimus dorsi flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-centre, non-randomized interventional study in a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery for unilateral breast reconstruction
Arm Type
Experimental
Arm Description
Patients treated in oncological surgery at the Center Georges-François Leclerc (CGFL) in Dijon for unilateral breast reconstruction after therapeutic total mastectomy.
Before the surgery, 2 questionnaires will be completed by patients : BREAST-Q and DASH. Also, the isokinetic test and EMG will be performed.
After the surgery, 2 questionnaires will be completed at one month, 3 months and 6 months. The Two tests will be performed at 3 moths and 6 months after the surgery.
Intervention Type
Procedure
Intervention Name(s)
Surgery for unilateral breast reconstruction
Intervention Description
Before the surgery, patient will be completed two questionnaire DASH and BREAST-Q. Two tests will be performed (isokinetic test and EMG).
After the surgery, at one month : 2 Questionnaires (DASH / BREAST-Q) will be performed At three months and six months : 2 questionnaires + two tests will be perfomed
Primary Outcome Measure Information:
Title
Measurement of the muscular moment
Description
Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction
Time Frame
During the 6 months post operation
Secondary Outcome Measure Information:
Title
Evaluation of muscle moments
Description
Evaluation of muscle moments, isokinetic measurements, performed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi (measurements before surgery, at 3 and 6 months)
Time Frame
During the 6 months post operation
Title
Comparison of muscular moments
Description
Comparison of muscular moments on the operated and "healthy" sides at 3 months and 6 months. Perfomed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi
Time Frame
During the 6 months post operation
Title
Calculation of adduction deficit
Description
Calculation of adduction deficit is defined as a relative difference of more than 5% compared to the measurement taken preoperatively. Patients who completed at least one physiotherapy session post-surgery and before 3 months will be compared to the others.
Time Frame
During the 6 months post operation
Title
Measurement of surface electromyographic activity
Description
Measurement of surface electromyographic activity (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months and 6 months post-surgery
Time Frame
During the 6 months post operation
Title
Functional clinical impact and quality of life
Description
Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery.
The DASH self-questionnaire is an upper limb function assessment scale. It offers the ability to perform 23 activities, the severity of the symptoms and optional sports or instrumental and professional activity.
Time Frame
During the 6 months post operation
Title
Functional clinical impact and quality of life
Description
Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery.
The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction.
Time Frame
During the 6 months post operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
Age between 18 and 80 years old
Signature of free and informed consent
Exclusion Criteria:
Patient with metastasis or disease progression
Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
Patient with a poor understanding of the French language
Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
Patient with a history of contralateral MR (all techniques combined)
Patient with a history of contralateral breast cancer
Patient does not have internet access to be able to connect to the "Exolis" software
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémentine CJ JANKOWSKI, Doctor
Phone
03 80 73 75 08
Email
cjankowski@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Paul PO ORNETTI, Professor
Email
paul.ornetti@chu-dijon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clémentine CJ JANKOWSI, Dr
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges-François Leclerc
City
Dijon
State/Province
Côte d'Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOPHIE PARNALLAND
Phone
0345 34 80 77
Ext
+33
Email
sparnalland@cgfl.fr
12. IPD Sharing Statement
Learn more about this trial
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
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