NCT04515459

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
40mo left

Started Sep 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Sep 2022Nov 2029

First Submitted

Initial submission to the registry

August 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

7.1 years

First QC Date

August 10, 2020

Last Update Submit

September 11, 2025

Conditions

Sarcoma

Keywords

Bone sarcomaSoft-tissue sarcomaPre-operative prehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 (10)

  • Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).

    26 months for each patient.

  • Anxiety using the Hospital Anxiety and Depression Scale (HADS).

    26 months for each patient.

  • Depression using the Hospital Anxiety and Depression Scale (HADS).

    26 months for each patient.

  • The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.

    26 months for each patient.

  • The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.

    26 months for each patient.

  • +5 more secondary outcomes

Study Arms (1)

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

OTHER
Other: Surgical prehabilitation program.

Interventions

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.

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 16 years old.
  • Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "RĂ©seau 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

RECRUITING

MeSH Terms

Conditions

SarcomaBone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Dimitri GANGLOFF

CONTACT

05 31 15 53 58gangloff.dimitri@iuct-oncopole.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 17, 2020

Study Start

September 13, 2022

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

FR(1)