Efficacy of Pre-operative Prehabilitation in Patients Wit... | NCT04515459

Studies
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

NCT04515459

Sponsor

Institut Claudius Regaud

Status

Recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

53Estimated

Phase

Phase 2

Conditions

Sarcoma

Interventions

Surgical prehabilitation program.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2022Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 14, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 15, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated for bone or soft-tissue sarcoma of the limbs	Other		Other: Surgical prehabilitation program.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical prehabilitation program.	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery.		26 months for each patient.

Secondary Outcomes

Measure	Description	Time Frame
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).	Quality of life will be evaluated from OTE1 to OTE8.	26 months for each patient.
Anxiety using the Hospital Anxiety and Depression Scale (HADS).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012509	Sarcoma
D001859	Bone Neoplasms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009371	Neoplasms by Site