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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Characterization of Neuromuscular Function and Fatigue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 : Patients<br> | Other: Characterization of Neuromuscular Function and Fatigue<br>* at inclusion<br>|
| Other: Group 2 : healthy volunteers<br> | Other: Characterization of Neuromuscular Function and Fatigue<br>* at inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal isometric muscle strength for knee extensors | Measured with force sensors. Significant differences between the two groups will be assessed | At Inclusion | 

Secondary Outcome Measures

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