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NCT Number: NCT05128617

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin-cyclophosphamide

Drug

1 cycle of Epirubicin-cyclophosphamide

Other names: Epirubicin-endoxan

paclitaxel

Drug

1 cycle of Paclitaxel

Other names: Taxol

Primary outcomes

  1. Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Western Blots measurements of protein expression levels

Secondary outcomes

  1. Investigate the acute effect of chemotherapy administration on structural alterations

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Cross-Sectional Area (CSA) measurements

  2. Investigate the acute effect of chemotherapy administration on inflammation

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Western Blots measurments of protein expression levels

  3. Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Western Blot measurement of protein expression levels

  4. Investigate the acute effect of chemotherapy administration on fatty infiltrations

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Western Blot measurement of protein expression levels

  5. Investigate the acute effect of chemotherapy administration on satellite cells

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in Western Blot measurement of protein expression levels

  6. .Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in quantity of muscle mass measured by bioelectrical impedance analysis

  7. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in the maximal isometric strength of the knee with force transducer

  8. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in ultrasonography measurement

  9. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in ultrasonography measurement

  10. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in ultrasonography measurement

  11. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in ultrasonography measurement

  12. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in FACT-G auto-questionnaire measurement

  13. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in FAACT auto-questionnaire measurement

  14. Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level

    Time frame: Before and 4 days after the chemotherapy

    Change From Baseline in GPAQ auto-questionnaire measurement

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Collaborators

  • Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire

Registry information

Acronym: PROTECT-06

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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