Clinical trial NCT04639609: Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)
Official title: Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire
First posted: 2020-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal isometric muscle strength for knee extensors
timeFrame: At Inclusion
Secondary outcomes:
measure: Number of Participants with neuromuscular fatigue
timeFrame: At Inclusion
measure: Number of Participants with neuromuscular fatigue
timeFrame: At Inclusion
measure: Number of Participants with neuromuscular fatigue
timeFrame: At Inclusion
measure: Number of Participants with subjective fatigue.
timeFrame: At Inclusion
measure: Number of Participants with muscle architecture.
timeFrame: At Inclusion
measure: Number of Participants with body composition.
timeFrame: At Inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
Study officials:
References: