Breast Cancer
Conditions
Brief summary
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of : * one group of patients receiving anthracyclines and taxanes * a second group of patients receiving anthracyclines, taxanes and trastuzumab.
Interventions
OTHERMicrobiopsy sample
before and after chemotherapy
OTHERMuscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy
Sponsors
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
Institut de cancérologie Strasbourg Europe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For group 1 without trastuzumab : * Patients must be ≥ 18 years old * Patients with breast cancer stage I to III * Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab * Patients must have a social security coverage * Patients able to speak, read and understand French For group 2 with trastuzumab : * Patients must be ≥ 18 years old * Patients with breast cancer grade I to III * Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab * Patients must have a social security coverage * Patients able to speak, read and understand French
Exclusion criteria
* History of cancer * Previous chemotherapy * Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease) * Pacemaker implantation * Contraindication to physical condition evaluation * Contraindication to local anesthesia required for microbiopsy * Patients \< 18 years old or patients ≥ 18 years old under guardianship, or supervision * Psychiatric, musculoskeletal or neurologic disorders * Women that are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vastus lateralis cross-sectional area | Between Week 18 and 24 after chemotherapy | Measured from muscle microbiopsy sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alteration of patients body composition | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | Assessment using bio-impedance analysis |
| Alteration of patients strength | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | Assessment of maximal isometric muscle strength for knee extensors measured with force sensors. |
| Alteration of patients muscle architecture | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | Assessment using muscle ultrasonography |
| Alteration of patients quality of life | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3) |
| Evaluation of patient cachexia | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4) |
Countries
France
Outcome results
None listed