NCT04515459 Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
| NCT ID | NCT04515459 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institut Claudius Regaud |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2022-09-13 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 53 participants in total. It began in 2022-09-13 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase II feasibility study, prospective, interventional, monocentric aiming to assess the interest of pre-operative rehabilitation in patients treated for bone or soft-tissue sarcoma of the limbs. This protocol will be based on the realisation of a surgical prehabilitation program adapted to the patient. This strategy will involve a team of several health professionals: rehabilitation doctor, physiotherapist, occupational therapist, specialised nurse, dietician and adapted physical activity teacher. The aim of an adapted surgical prehabilitation program is to improve the functional recovery of the treated limb and the patient's autonomy after surgery. Each patient will be followed until 24 months post surgery.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04515459 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04515459 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04515459 currently recruiting?
Yes, NCT04515459 is actively recruiting participants. Contact the research team at gangloff.dimitri@iuct-oncopole.fr for enrollment information.
Where is the NCT04515459 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT04515459 clinical trial?
NCT04515459 is sponsored by Institut Claudius Regaud. The trial plans to enroll 53 participants.