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Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study

Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05128617
Acronym
PROTECT-06
Enrollment
20
Registered
2021-11-22
Start date
2021-11-04
Completion date
2023-05-30
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Protein turnover, Skeletal muscle deconditoning, Breast cancer, Chemotherapy, Muscle biopsy

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.

Interventions

DRUGEpirubicin-cyclophosphamide

1 cycle of Epirubicin-cyclophosphamide

DRUGPaclitaxel

1 cycle of Paclitaxel

Sponsors

Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire
CollaboratorUNKNOWN
Institut de cancérologie Strasbourg Europe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patientsBefore and 4 days after the chemotherapyChange From Baseline in Western Blots measurements of protein expression levels

Secondary

MeasureTime frameDescription
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of lifeBefore and 4 days after the chemotherapyChange From Baseline in FACT-G auto-questionnaire measurement
Investigate the acute effect of chemotherapy administration on structural alterationsBefore and 4 days after the chemotherapyChange From Baseline in Cross-Sectional Area (CSA) measurements
Investigate the acute effect of chemotherapy administration on inflammationBefore and 4 days after the chemotherapyChange From Baseline in Western Blots measurments of protein expression levels
Investigate the acute effect of chemotherapy administration on mitochondrial homeostasisBefore and 4 days after the chemotherapyChange From Baseline in Western Blot measurement of protein expression levels
Investigate the acute effect of chemotherapy administration on fatty infiltrationsBefore and 4 days after the chemotherapyChange From Baseline in Western Blot measurement of protein expression levels
Investigate the acute effect of chemotherapy administration on satellite cellsBefore and 4 days after the chemotherapyChange From Baseline in Western Blot measurement of protein expression levels
.Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle massBefore and 4 days after the chemotherapyChange From Baseline in quantity of muscle mass measured by bioelectrical impedance analysis
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle forceBefore and 4 days after the chemotherapyChange From Baseline in the maximal isometric strength of the knee with force transducer
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thicknessBefore and 4 days after the chemotherapyChange From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennationBefore and 4 days after the chemotherapyChange From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle lengthBefore and 4 days after the chemotherapyChange From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecityBefore and 4 days after the chemotherapyChange From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite lossBefore and 4 days after the chemotherapyChange From Baseline in FAACT auto-questionnaire measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity levelBefore and 4 days after the chemotherapyChange From Baseline in GPAQ auto-questionnaire measurement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026