Breast Cancer, Breast Reconstruction, Latissimus Dorsi Flap, Physiotherapy
Conditions
Brief summary
Each year in France, nearly 59,000 new cases of breast cancer are diagnosed, and approximately 22,000 mastectomies are performed. Among these patients, 30% choose to undergo breast reconstruction. Breast cancer leads to numerous physical and psychological changes. The need to strengthen patient support around breast reconstruction has been highlighted, and it is one of the priorities of the national Ten-Year Cancer Control Strategy. The growing number of patients living after cancer makes the management of post-treatment sequelae essential. The rate of reconstruction is increasing thanks to improvements in technique and better access to information. Among the available options, the latissimus dorsi (LD) flap has been a standard technique for immediate and delayed breast reconstruction for over 25 years. The LD technique offers several advantages: high reliability, feasibility even in irradiated thoraxes, low rates of postoperative complications, and satisfactory aesthetic outcomes. Its versatility and reliability have made it a cornerstone of breast surgery. However, this technique can lead to short- and long-term functional sequelae, which persist in 10% of patients. To reduce these side effects, an optimized version-the lipofilled mini-latissimus dorsi flap (mLD)-was developed by a team in Strasbourg. This quicker and less muscle-invasive technique is mainly used for immediate reconstruction or to replace implant-based reconstruction, with systematic lipofilling. However, no objective functional assessment of this method has yet been carried out, justifying a stratification according to the type of procedure for randomization in future studies. According to a prospective Icelandic study involving 15 patients, full recovery can be expected, but patients must be informed of the time and effort required to achieve it. The authors also concluded that further research is necessary to better understand the limits of long-term recovery. A study of 450 LD reconstructions showed that pain and the main functional sequelae were located in the back and shoulder, with 10% of patients experiencing significant long-term pain. In addition, according to this study, around 40% of patients consider postoperative sequelae and scarring burdensome. However, regret rates remain low, at under 3%. In view of these findings, preventing pain and functional impairment has become a key research focus to improve patients' quality of life. Postoperative rehabilitation plays a crucial role in managing pain, reducing functional impairment, and optimizing aesthetic outcomes. The addition of mechanostimulation (MS) has been shown to improve scar appearance, shoulder function, and functional well-being compared with rehabilitation alone. MS is delivered using a device equipped with motorized rollers and suction to mobilize tissues. In physiotherapy, it helps relieve pain and improve mobility. Prehabilitation, a rapidly expanding concept in surgery, aims to prepare patients before their procedure. However, to date, no prehabilitation approach combining physiotherapy and MS has been considered prior to LD flap surgery. One study highlighted improved tissue trophicity after tissue preparation with MS before lipomodelling. The objective of our study is to evaluate the benefit of prehabilitation through physiotherapy incorporating MS to prepare tissues (in particular skin and muscle) on shoulder pain and functional outcomes in patients undergoing breast reconstruction with a latissimus dorsi flap. Additionally, due to the heterogeneity and sometimes limited access to specialized postoperative physiotherapy, extensive patient follow-up has been planned in order to describe, on an exploratory basis, real-world rehabilitation practices.
Interventions
OTHERPrehabilitation with physiotherapy including mechanostimulation
a preoperative physiotherapy program including a minimum of 6 and up to 8 sessions, at a frequency of 2 sessions per week. These sessions may be performed in private practice or at the investigational center.
OTHERNo Prehabilitation with physiotherapy including mechanostimulation
No intervention
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patient aged 18 years or older * Scheduled for breast reconstruction with a latissimus dorsi flap following breast cancer * Patient has been informed and has signed the informed consent form * Affiliated with a social security system
Exclusion criteria
* Patient with pre-existing shoulder pathology (Constant score \< 80/100) * Patient with uncontrolled psychiatric or mental disorders * Patient unable to understand French * Patient under guardianship or safeguard of justice * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation. | at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap | Constant score assessed at Day 30 post-surgery. Note: The Constant score evaluates the shoulder across four dimensions: 1) Pain, 2) Shoulder function, 3) Active range of motion of the shoulder, and 4) Muscle strength. The Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the progression of shoulder function | at baseline and Months 3, 6, and 12 post-surgery | constant score Note: The Constant score evaluates the shoulder across four dimensions: 1) Pain, 2) Shoulder function, 3) Active range of motion of the shoulder, and 4) Muscle strength. The Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function. |
| Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain. |
| Evaluation of the changes in disability and severity of symptoms in the operated-side shoulder | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | "Disabilities of the Arm, Shoulder, and Hand" questionnaire score (DASH) DASH questionnaire Scale from 0 to 100, with 0 indicating no disability and 100 indicating total disability. |
| Evaluation of the changes in range of motion in the operated-side shoulder | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation |
| Evaluation of the Forward flexion flexibility | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Finger-to-floor distance in cm |
| Evaluation of the flexibility, height, vascularization, and pigmentation of the dorsal scar | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar |
| Evaluation of the number of lymphatic fluid aspirations and the aspirated volume in the postoperative period | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file |
| Evaluation of the number of physiotherapy sessions with and without mechanostimulation | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Number of physiotherapy sessions with and without mechanostimulation |
| Evaluation of the changes in quality of life by Quality of Life Questionnaire | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). All scale scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms |
| Evaluation of the changes in quality of life according of Quality of Life Questionnaire specify for Breast Cancer | at baseline, Day 30, and at Months 3, 6, and 12 post-surgery | Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR42). Scores for each scale are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms. |
| Evaluation of the return to work, measured by the number of weeks before resuming employment | at Months 3, 6, and 12 post-surgery only | assessment of the time to return to work, expressed in weeks |
Countries
France
Contacts
CONTACTAurore MOUSSION
STUDY_DIRECTORKerstin FARAVEL
ICM Montpellier
Outcome results
None listed