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

Breast Cancer Clinical Trial

— PROTECT-06  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128617
• Other study ID #: 2021-004
• Status: Completed
• Start date: November 4, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Epirubicin-cyclophosphamide
1 cycle of Epirubicin-cyclophosphamide
• Paclitaxel
1 cycle of Paclitaxel

Locations

Country	Name	City	State
France	Institut de Cancerologie Strasbourg Europe	Strasbourg

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	.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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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