Clinical trial NCT05128617: Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
Official title: Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Protein turnover
Skeletal muscle deconditoning
Breast cancer
Chemotherapy
Muscle biopsy
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire
First posted: 2021-11-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment

Brief summary: Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.

Detailed description: Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.

Eligibility criteria: Inclusion Criteria:

* Breast cancer (stade I to III)
* Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment

Exclusion Criteria:

* History of cancer
* Known chronic pathology
* Pacemaker
* Contraindication to the evaluation of the physical condition
* Contraindication to the local anesthesia for the muscle micro-biopsy
* Breastfeeding or pregnant woman

Primary outcomes:
measure: Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
timeFrame: Before and 4 days after the chemotherapy
Secondary outcomes:
measure: Investigate the acute effect of chemotherapy administration on structural alterations
timeFrame: Before and 4 days after the chemotherapy
measure: Investigate the acute effect of chemotherapy administration on inflammation
timeFrame: Before and 4 days after the chemotherapy
measure: Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis
timeFrame: Before and 4 days after the chemotherapy
measure: Investigate the acute effect of chemotherapy administration on fatty infiltrations
timeFrame: Before and 4 days after the chemotherapy
measure: Investigate the acute effect of chemotherapy administration on satellite cells
timeFrame: Before and 4 days after the chemotherapy
measure: .Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss
timeFrame: Before and 4 days after the chemotherapy
measure: Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level
timeFrame: Before and 4 days after the chemotherapy
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
Study officials:
References: