Evaluating muscle function after breast reconstruction using a minimally invasive technique.
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
NA · Centre Georges Francois Leclerc · NCT05278741
This study is testing how well the muscles work in women who have breast reconstruction surgery using a special technique to see how their recovery goes over the first year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Centre Georges Francois Leclerc (other) |
| Locations | 1 site (Dijon, Côte d'Or) |
| Trial ID | NCT05278741 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the muscle function of patients undergoing unilateral breast reconstruction with a minimally invasive latissimus dorsi flap following radical surgery for breast cancer. It will utilize a variety of measures, including clinical assessments, isokinetic tests, electrophysiology, and quality of life questionnaires, to evaluate the latissimus dorsi muscle's capacity at multiple time points: before surgery, and at 3, 6, and 12 months post-surgery. The study anticipates a temporary functional deficit at 3 months, with a return to preoperative function by 6 and 12 months. This comprehensive approach allows for an objective evaluation of recovery and rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 who are undergoing unilateral breast reconstruction after therapeutic mastectomy.
Not a fit: Patients with metastasis, significant neurocognitive or orthopedic disorders, or those who do not understand French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery protocols and improve quality of life for breast cancer patients undergoing reconstruction.
How similar studies have performed: Other studies have shown promising results with similar minimally invasive approaches in breast reconstruction, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Dijon, Côte d'Or
- Centre Georges-François Leclerc — Dijon, Côte d'Or, France (RECRUITING)
Study contacts
- Principal investigator: Clémentine CJ JANKOWSI, Dr — Centre Georges François Leclerc
- Study coordinator: Clémentine CJ JANKOWSKI, Doctor
- Email: cjankowski@cgfl.fr
- Phone: 03 80 73 75 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast, Latissimus dorsi flap