A Phase 2 interventional study of Surgical prehabilitation program. in Sarcoma, sponsored by Institut Claudius Regaud. Recruiting at 1 site in France. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Institut Claudius Regaud · Phase 2, Interventional, and Other
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.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 53 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Surgical prehabilitation program.
This programme will include the practice of general physical activity and the implementation of nutritional and psychological support. Each patient will have 8 Oncorehabilitation Transdisciplinary Evaluations (OTE): * 2 OTE will be performed before the surgery, * 6 OTE will be performed after the surgery. During the program (at each OTE), patients will also be asked to complete the QLQ-C30 questionnaire.
Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery.
Time frame: 26 months for each patient.
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Quality of life will be evaluated from OTE1 to OTE8.
Time frame: 26 months for each patient.
Anxiety using the Hospital Anxiety and Depression Scale (HADS).
Seven item subscale. Each item is scored on a 4-point scale. Anxiety will be evaluated from OTE1 to OTE8.
Time frame: 26 months for each patient.
Depression using the Hospital Anxiety and Depression Scale (HADS).
Seven item subscale. Each item is scored on a 4-point scale. Depression will be evaluated from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the New Functional Ambulation Classification test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Box and Block Test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Frenchay Arm Test from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Visual Analog Scale from OTE1 to OTE8.
Time frame: 26 months for each patient.
The patient functionality will be evaluated using the Ricci and Gagnon's Score from OTE1 to OTE8.
Time frame: 26 months for each patient.
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