Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)

Overview

This is a transversal monocentric study comparing two groups of women (group 1, patient group : patients who have been treated for a breast cancer with taxane-based chemotherapy ; group 2, control group : healthy volunteers). The aim of this study is to evaluate if a difference exists regarding the maximal isometric muscle strength between group 1 and 2.

Full Title of Study: “Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 29, 2021

Detailed Description

All subjects will be evaluated a single time during two hours. For patients from group 1 the evaluation should take place within the two weeks that follow the end of adjuvant treatment. There is no specificity regarding evaluation of volunteers from group 2, their evaluation can take place at any time.

Interventions

  • Other: Characterization of Neuromuscular Function and Fatigue
    • at inclusion

Arms, Groups and Cohorts

  • Experimental: Group 1 : Patients
  • Other: Group 2 : healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

  • Maximal isometric muscle strength for knee extensors
    • Time Frame: At Inclusion
    • Measured with force sensors. Significant differences between the two groups will be assessed

Secondary Measures

  • Number of Participants with neuromuscular fatigue
    • Time Frame: At Inclusion
    • Assessment using surface electromyography. Significant differences between the two groups will be assessed.
  • Number of Participants with neuromuscular fatigue
    • Time Frame: At Inclusion
    • Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.
  • Number of Participants with neuromuscular fatigue
    • Time Frame: At Inclusion
    • Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.
  • Number of Participants with subjective fatigue.
    • Time Frame: At Inclusion
    • Questionnaire Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-F) version 4. Significant differences between the two groups will be assessed.
  • Number of Participants with muscle architecture.
    • Time Frame: At Inclusion
    • Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
  • Number of Participants with body composition.
    • Time Frame: At Inclusion
    • Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.

Participating in This Clinical Trial

Inclusion Criteria : Group 1 – Patients :

  • Give written inform consent – Age ≥ 18 years – Affiliate to social security system – Ability to speak, understand and read French – Breast cancer, Stage II or III, treated by taxane-based chemotherapy Group 2 – Control group : – Give written inform consent – Age ≥ 18 years – Affiliate to social security system – Ability to speak, understand and read French Exclusion Criteria:
  • Group 1 – Patients :

  • < 18 years old or patients ≥ 18 years old under guardianship, or supervision – Psychiatric, musculoskeletal or neurologic disorders – Patients presenting one of the following contraindications to transcranial magnetic stimulation : – Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.) – History of epilepsy – Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic) – Women that are pregnant – Serious or recent heart disease Group 2 -Control group : – < 18 years old or patients ≥ 18 years old under guardianship, or supervision – Psychiatric, musculoskeletal or neurologic disorders – Pacemaker implantation – History of cancer – All known chronic disease – Subjects presenting one of the following contraindications to transcranial magnetic stimulation : – Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.) – History of epilepsy – Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic) – Women that are pregnant – Serious or recent heart disease
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Institut de cancérologie Strasbourg Europe
    • Collaborator
      • UR 3072 – Mitochondrie, Stress oxydant et Protection musculaire
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Contact(s)
      • Valérie SARTORI, 368767223, v.sartori@icans.eu

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