Pre-operative rehabilitation for patients with limb sarcoma
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
This study is testing a pre-surgery rehab program to see if it helps people with limb sarcoma recover better and regain their independence after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04515459 on ClinicalTrials.gov |
What this trial studies
This Phase II interventional study aims to evaluate the effectiveness of a pre-operative rehabilitation program for patients diagnosed with bone or soft-tissue sarcoma in the limbs. The program involves a multidisciplinary team, including rehabilitation doctors, physiotherapists, occupational therapists, specialized nurses, dieticians, and adapted physical activity instructors, to enhance functional recovery and patient autonomy post-surgery. Patients will be monitored for up to 24 months following their surgical intervention to assess outcomes related to their rehabilitation.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 and older with a confirmed diagnosis of localized or metastatic bone or soft-tissue sarcoma in the limbs who are scheduled for surgery.
Not a fit: Patients with sarcomas located outside the limbs or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery times and quality of life for patients undergoing surgery for limb sarcoma.
How similar studies have performed: While there is emerging interest in prehabilitation for surgical patients, this specific approach for limb sarcoma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> or = 16 years old. 2. Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)" 3. Tumour localized in the lower or upper limb. 4. Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed). 5. Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting. 6. Inclusion before the initiation or during neoadjuvant treatment. In both cases, surgery must be scheduled between 6 and 10 weeks after inclusion, to permit the completion of the surgical prehabilitation. 7. Patient must provide written informed consent prior to any study-specific procedure. For minor patients, the holder(s) of parental authority must sign the informed consent and the patient's assent must be obtained. 8. Patient affiliated to the French social security system. Exclusion Criteria: 1. Metastatic disease without optimal surgery planned of the primary tumour. 2. Any disease or medical condition that could interfere with study procedure, or that could, according to the judgment of investigator, expose the patient to an unacceptable risk. 3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice). 4. Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure. 5. Pregnant or breastfeeding patient.
Where this trial is running
Toulouse
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Dimitri GANGLOFF
- Email: gangloff.dimitri@iuct-oncopole.fr
- Phone: 05 31 15 53 58
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.