Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
NCT ID: NCT04638712
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2020-09-16
2021-05-20
Brief Summary
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* one group of patients receiving anthracyclines and taxanes
* a second group of patients receiving anthracyclines, taxanes and trastuzumab.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1 without trastuzumab
Microbiopsy sample
before and after chemotherapy
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy
Group 2 with trastuzumab
Microbiopsy sample
before and after chemotherapy
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy
Interventions
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Microbiopsy sample
before and after chemotherapy
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
UNKNOWN
Institut de cancérologie Strasbourg Europe
OTHER
Responsible Party
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Locations
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Institut de Cancerologie Strasbourg Europe
Strasbourg, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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2020-A01266-33
Identifier Type: OTHER
Identifier Source: secondary_id
2020-006
Identifier Type: -
Identifier Source: org_study_id
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