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

Primary Purpose

Sarcoma

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Surgical prehabilitation program.
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sarcoma focused on measuring Bone sarcoma, Soft-tissue sarcoma, Pre-operative prehabilitation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with a MSTS score (Musculoskeletal Tumor Rating Scale) greater than 75% at 24 months post-surgery.

Secondary Outcome Measures

Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Quality of life will be evaluated from OTE1 to OTE8.
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.
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.
The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.
The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.
The patient functionality will be evaluated using the New Functional Ambulation Classification test from OTE1 to OTE8.
The patient functionality will be evaluated using the Box and Block Test from OTE1 to OTE8.
The patient functionality will be evaluated using the Frenchay Arm Test from OTE1 to OTE8.
The patient functionality will be evaluated using the Visual Analog Scale from OTE1 to OTE8.
The patient functionality will be evaluated using the Ricci and Gagnon's Score from OTE1 to OTE8.

Full Information

First Posted
August 10, 2020
Last Updated
September 20, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT04515459
Brief Title
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
Acronym
EPOP-SARCOMA
Official Title
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Bone sarcoma, Soft-tissue sarcoma, Pre-operative prehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients treated for bone or soft-tissue sarcoma of the limbs
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Surgical prehabilitation program.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Quality of life using the Quality Of Life Questionnaire Core 30 (QLQ-C30).
Description
Quality of life will be evaluated from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
Anxiety using the Hospital Anxiety and Depression Scale (HADS).
Description
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.
Title
Depression using the Hospital Anxiety and Depression Scale (HADS).
Description
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.
Title
The patient functionality will be evaluated using the Tinetti's test from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the 6-min walk test from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the New Functional Ambulation Classification test from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the Box and Block Test from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the Frenchay Arm Test from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the Visual Analog Scale from OTE1 to OTE8.
Time Frame
26 months for each patient.
Title
The patient functionality will be evaluated using the Ricci and Gagnon's Score from OTE1 to OTE8.
Time Frame
26 months for each patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri GANGLOFF
Phone
05 31 15 53 58
Email
gangloff.dimitri@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri GANGLOFF
Phone
05 31 15 53 58
Email
gangloff.dimitri@iuct-oncopole.fr

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

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