An interventional study of Prehabilitation with physiotherapy including mechanostimulation and No Prehabilitation with physiotherapy including mechanostimulation in Breast Cancer, Physiotherapy and Breast Reconstruction, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Prevention
Among 44 studies in Breast Neoplasms by Institut du Cancer de Montpellier - Val d'Aurelle — 14 open to participants now, 17 under way, none of them phase 3. Breast Neoplasms · Institut du Cancer de Montpellier - Val d'Aurelle.
Among the 44 studies in Breast Neoplasms by Institut du Cancer de Montpellier - Val d'Aurelle, this one is the 23rd largest by planned enrollment of the 38 interventional ones that give a count, is the only one that started in 2026, is one of 29 with no phase, reaches primary completion later than 15 of the 16 other live ones, and was the 44th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →14 of the 44 studies in Breast Neoplasms by Institut du Cancer de Montpellier - Val d'Aurelle are open now, in 1 country. Recruiting first, the newest first:
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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44 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 96 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 148 across the 38 interventional studies, 373 across the 6 observational. Of the 26 that completed or were terminated, 2 (8%) have results posted.
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Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.
4 of the studies in Breast Neoplasms by Institut du Cancer de Montpellier - Val d'Aurelle that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04469296Institut du Cancer de Montpellier - Val d'AurelleDiet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery | 2026-12 |
| NCT06265558Institut du Cancer de Montpellier - Val d'AurellePrevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery | 2027-05 |
| NCT06415266Institut du Cancer de Montpellier - Val d'AurelleAssessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request | 2027-08 |
| NCT03449264Institut du Cancer de Montpellier - Val d'AurelleDevelopment of Clinical and Biological Database | 2027-11 |
Among the 44 studies in Breast Neoplasms by Institut du Cancer de Montpellier - Val d'Aurelle, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prehabilitation with physiotherapy including mechanostimulation: a minimum of 6 and up to 8 sessions between inclusion and surgery, at a frequency of 2 sessions per week
Other: Prehabilitation with physiotherapy including mechanostimulation
No prehabilitation
Other: No Prehabilitation 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.
No intervention
evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.
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.
Time frame: at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap
Evaluation of the progression of shoulder function
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.
Time frame: at baseline and Months 3, 6, and 12 post-surgery
Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale
Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in disability and severity of symptoms in the operated-side shoulder
"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.
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in range of motion in the operated-side shoulder
Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the Forward flexion flexibility
Finger-to-floor distance in cm
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the flexibility, height, vascularization, and pigmentation of the dorsal scar
Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the number of lymphatic fluid aspirations and the aspirated volume in the postoperative period
Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the number of physiotherapy sessions with and without mechanostimulation
Number of physiotherapy sessions with and without mechanostimulation
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in quality of life by Quality of Life Questionnaire
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
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in quality of life according of Quality of Life Questionnaire specify for Breast Cancer
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.
Time frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the return to work, measured by the number of weeks before resuming employment
assessment of the time to return to work, expressed in weeks
Time frame: at Months 3, 6, and 12 post-surgery only
Plan to share: Yes — All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
Access criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2030, 47 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 47 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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