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

September 20, 2023 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients treated for bone or soft-tissue sarcoma of the limbs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
26 months for each patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Time Frame: 26 months for each patient.
Quality of life will be evaluated from OTE1 to OTE8.
26 months for each patient.
Anxiety using the Hospital Anxiety and Depression Scale (HADS).
Time Frame: 26 months for each patient.
Seven item subscale. Each item is scored on a 4-point scale. Anxiety will be evaluated from OTE1 to OTE8.
26 months for each patient.
Depression using the Hospital Anxiety and Depression Scale (HADS).
Time Frame: 26 months for each patient.
Seven item subscale. Each item is scored on a 4-point scale. Depression will be evaluated from OTE1 to OTE8.
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.
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.
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.
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.
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.
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.
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.
26 months for each patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20 SARC 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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