NCT04515459RecruitingPhase 2
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- First submitted
- 10 Aug 2020
- Start date
- 13 Sept 2022
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04515459
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 53
- From 13 Sept 2022 to the primary completion date, 30 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Metastatic disease without optimal surgery planned of the primary tumour.
- 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.
Other
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
- Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
- Pregnant or breastfeeding patient.
Who the study is looking for
- Age \> or = 16 years old.
- Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)"
- Tumour localized in the lower or upper limb.
- Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed).
- Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting.
- 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.
- 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.
- Patient affiliated to the French social security system.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Universitaire du Cancer de Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.