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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Epirubicin-cyclophosphamide; Drug: Paclitaxel

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67033
    • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epirubicin-cyclophosphamide; Woman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide	Drug: Epirubicin-cyclophosphamide; 1 cycle of Epirubicin-cyclophosphamide; Other Names: Epirubicin-endoxan
Paclitaxel; Woman with early breast cancer receiving a first cycle of paclitaxel	Drug: Paclitaxel; 1 cycle of Paclitaxel; Other Names: Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients	Change From Baseline in Western Blots measurements of protein expression levels	Before and 4 days after the chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the acute effect of chemotherapy administration on structural alterations	Change From Baseline in Cross-Sectional Area (CSA) measurements	Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on inflammation	Change From Baseline in Western Blots measurments of protein expression levels	Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis	Change From Baseline in Western Blot measurement of protein expression levels	Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on fatty infiltrations	Change From Baseline in Western Blot measurement of protein expression levels	Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on satellite cells	Change From Baseline in Western Blot measurement of protein expression levels	Before and 4 days after the chemotherapy
.Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass	Change From Baseline in quantity of muscle mass measured by bioelectrical impedance analysis	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force	Change From Baseline in the maximal isometric strength of the knee with force transducer	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness	Change From Baseline in ultrasonography measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation	Change From Baseline in ultrasonography measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length	Change From Baseline in ultrasonography measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity	Change From Baseline in ultrasonography measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life	Change From Baseline in FACT-G auto-questionnaire measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss	Change From Baseline in FAACT auto-questionnaire measurement	Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level	Change From Baseline in GPAQ auto-questionnaire measurement	Before and 4 days after the chemotherapy

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Collaborators: Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Chemotherapy; Muscle biopsy; Protein turnover; Skeletal muscle deconditoning
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Paclitaxel; Epirubicin
• Other Study ID Numbers: 2021-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No