Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

Who is this study for? Child to adult patients with Sarcoma
What treatments are being studied? Surgical Prehabilitation
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Universitaire du Cancer de Toulouse - Oncopole
RECRUITING
Toulouse
Contact Information
Primary
Dimitri GANGLOFF
gangloff.dimitri@iuct-oncopole.fr
05 31 15 53 58
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2029-11
Participants
Target number of participants: 53
Treatments
Other: Patients treated for bone or soft-tissue sarcoma of the limbs
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov