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

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Recruiting

CT.gov ID

NCT05128617

Collaborator

Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire (Other)

Enrollment

Location

10.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 4, 2021

Anticipated Primary Completion Date :

Sep 28, 2022

Anticipated Study Completion Date :

Sep 28, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Investigate the acute effect of chemotherapy administration on structural alterations [Before and 4 days after the chemotherapy]
Change From Baseline in Cross-Sectional Area (CSA) measurements
Investigate the acute effect of chemotherapy administration on inflammation [Before and 4 days after the chemotherapy]
Change From Baseline in Western Blots measurments of protein expression levels
Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis [Before and 4 days after the chemotherapy]
Change From Baseline in Western Blot measurement of protein expression levels
Investigate the acute effect of chemotherapy administration on fatty infiltrations [Before and 4 days after the chemotherapy]
Change From Baseline in Western Blot measurement of protein expression levels
Investigate the acute effect of chemotherapy administration on satellite cells [Before and 4 days after the chemotherapy]
Change From Baseline in Western Blot measurement of protein expression levels
.Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass [Before and 4 days after the chemotherapy]
Change 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 force [Before and 4 days after the chemotherapy]
Change 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 thickness [Before and 4 days after the chemotherapy]
Change From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation [Before and 4 days after the chemotherapy]
Change From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length [Before and 4 days after the chemotherapy]
Change From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity [Before and 4 days after the chemotherapy]
Change From Baseline in ultrasonography measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life [Before and 4 days after the chemotherapy]
Change From Baseline in FACT-G auto-questionnaire measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss [Before and 4 days after the chemotherapy]
Change From Baseline in FAACT auto-questionnaire measurement
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level [Before and 4 days after the chemotherapy]
Change From Baseline in GPAQ auto-questionnaire measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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