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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Institut de cancérologie Strasbourg europe

Strasbourg, France, 67033

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 | DecenTrialz