Clinical trial NCT04638712: Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
Official title: Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
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 - Mitochondries, Stress oxydant, Protection musculaire
First posted: 2020-11-20
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in vastus lateralis cross-sectional area
timeFrame: Between Week 18 and 24 after chemotherapy
Secondary outcomes:
measure: Alteration of patients body composition
timeFrame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
measure: Alteration of patients strength
timeFrame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
measure: Alteration of patients muscle architecture
timeFrame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
measure: Alteration of patients quality of life
timeFrame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
measure: Evaluation of patient cachexia
timeFrame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
Study officials:
References:
citation: Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCollection 2021.
citation: Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.
citation: Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.