Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

Breast Cancer Clinical Trial

— BREAST  

Official title:

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278741
• Other study ID #: 2021-A03166-35
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: May 25, 2025

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: Clémentine CJ JANKOWSKI, Doctor
• Phone: 03 80 73 75 08
• Email: cjankowski[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 25, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

• Inclusion Criteria:

1. Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.

2. Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months

3. Age between 18 and 80 years old

4. Signature of free and informed consent

• Exclusion Criteria:

1. Patient with metastasis or disease progression

2. 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)

3. Patient with a poor understanding of the French language

4. Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)

5. 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

6. Patient with a history of contralateral MR (all techniques combined)

7. Patient with a history of contralateral breast cancer

8. Patient does not have internet access to be able to connect to the "Exolis" software

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Surgery for unilateral breast reconstruction
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

Locations

Country	Name	City	State
France	Centre Georges-François Leclerc	Dijon	Côte d'Or

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the 6 months post operation
Secondary	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)	During the 6 months post operation
Secondary	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	During the 6 months post operation
Secondary	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.	During the 6 months post operation
Secondary	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	During the 6 months post operation
Secondary	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.	During the 6 months post operation
Secondary	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.	During the 6 months post operation