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

NCT06536556 | Terminated

• 1 other identifier: 2023-029
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.

Conditions

Breast Cancer

Keywords

Protein turnover; Skeletal muscle deconditoning; Breast cancer; Chemotherapy; Muscle biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change at 4 days post-treatment compare to baseline

Secondary Outcomes (1)

• 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

  Change at 4 days post-treatment compare to baseline

Study Arms (3)

TAX Group

Woman with early breast cancer receiving a first cycle of TAX

Other: First Assessment; Other: Second Assessment

TAX+TRASTU Group

Woman with early breast cancer receiving a first cycle of TAX+TRASTU

Other: First Assessment; Other: Second Assessment

TAX+CARBO Group

oman with early breast cancer receiving a first cycle of TAX+CARBO

Other: First Assessment; Other: Second Assessment

Interventions

First Assessment OTHER

pre-treatment assessment

TAX Group; TAX+CARBO Group; TAX+TRASTU Group

Second Assessment OTHER

4 days post-treatment assessment

TAX Group; TAX+CARBO Group; TAX+TRASTU Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early-stage breast cancer receiving chemotherapy. It is planned to include a first group of 10 patients receiving their first administration of TAX and a second group of 10 patients receiving their first administration of TAX+TRASTU. A first session of assessments will take place before the first TAX or TAX+TRASTU session, and a second session 4 days (D4) after the session. It is planned to include the same number of patients per group, i.e. 10 patients per group, for a total of 20 patients in the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg europe

Strasbourg, 67033, France

Location

Related Publications (1)

• Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.

  PMID: 36094434 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

muscle micro-biopsy

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: August 5, 2024
• Study Start: May 2, 2024
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)