Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study

Institut de cancérologie Strasbourg Europe5 enrolled

Overview

This study aims to investigate the acute effects (i.e. 4 days) of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients. Muscle biopsies will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.

Breast cancer patients are commonly treated with chemotherapy, which is known to induce severe side effects such as skeletal muscle deconditioning, characterized by skeletal muscle atrophy and major mitochondrial alterations. These maladaptations, observed in patients treated with epirubicin-cyclophosphamide (EC) followed by weekly paclitaxel (TAX), ultimately lead to reduction in exercise capacity and quality of life. However, little is known about the specific effect of each type of chemotherapy. In our recent article (see Citations field in the References module), The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent. Using muscle biopsies before and 4 days after the first administration of EC or TAX, we demonstrated that unlike TAX, EC induced severe muscle atrophy and mitochondrial alterations. Of note, patients in the TAX group had already received EC during the preceding weeks (Figure 1). Therefore, these patients had already begun to have altered skeletal muscle homeostasis, which might have limited the influence of TAX compared with that of its administration in isolation (i.e., without other previous chemotherapy administrations). In addition, some patients had received, concomitantly with TAX, Trastuzumab (TRASTU) due to HER tumor mutation. Also, in triple negative breast cancers, the recommendations concerning neo(adjuvant) chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel + carboplatin (TAX + CARBO).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

First AssessmentOTHER

pre-treatment assessment

Second AssessmentOTHER

4 days post-treatment assessment

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: TAX group : * Female ≥ 18 years * Stage I to III breast cancer * Patient who has not yet started treatment with TAX * Enrolled in a social security scheme * Able to speak, read and understand French TAX+TRASTU group : * Female ≥ 18 years of age * Stage I to III breast cancer * Patient who has not yet started treatment with TAX+TRASTU (Tolaney regimen) * Enrolled in a social security scheme * Able to speak, read and understand French Exclusion Criteria: * Prior exposure to chemotherapy * Musculoskeletal disorders, autoimmune, vascular or neuromuscular disease * Implantation of a pacemaker * Contraindications to fitness evaluation * Contraindication to local anesthesia for microbiopsy * Minor or protected adult * Pregnant women

Locations (1)

Institut de cancérologie Strasbourg europe

Strasbourg, France

Outcomes

Primary Outcomes

To investigate the effects of a chemotherapy session on mitochondrial function of skeletal muscle in breast cancer patients by comparing the first session of TAX to the first session of TAX + TRASTU or +CARBO.

difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.

Time frame: Change at 4 days post-treatment compare to baseline

Secondary Outcomes

Compare the effect of the first TAX to the first TAX+TRASTU or +CARBO on muscle fiber cross-sectional area;cellular mechanisms of inflammation,fat infiltration and protein turnover;body composition;strength;muscle architecture and quality of life

difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.

Time frame: Change at 4 days post-treatment compare to baseline

Data from ClinicalTrials.gov

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