Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma (EPOP-SARCOMA)

Institut Claudius Regaud

Status and phase: Enrolling; Phase 2

Conditions: Sarcoma

Treatments: Other: Surgical prehabilitation program.

Study type: Interventional

Funder types: Other

Identifiers

NCT04515459

20 SARC 03

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Patients treated for bone or soft-tissue sarcoma of the limbs

Other group

Treatment:

Other: Surgical prehabilitation program.