Status:
TERMINATED
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
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 w...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06536556
Start Date
May 2 2024
End Date
February 3 2025
Last Update
January 5 2026
Active Locations (1)
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1
Institut de cancérologie Strasbourg europe
Strasbourg, France, 67033