跳至主要内容
临床试验/NCT06536556
NCT06536556终止不适用

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 Europe1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

TAX Group

Woman with early breast cancer receiving a first cycle of TAX

干预措施: First Assessment (Other)

TAX Group

Woman with early breast cancer receiving a first cycle of TAX

干预措施: Second Assessment (Other)

TAX+TRASTU Group

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

干预措施: First Assessment (Other)

TAX+TRASTU Group

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

干预措施: Second Assessment (Other)

TAX+CARBO Group

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

干预措施: First Assessment (Other)

TAX+CARBO Group

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

干预措施: Second Assessment (Other)

结局指标

主要结局

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.

时间窗: Change at 4 days post-treatment compare to baseline

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.

次要结局

  • 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)

研究者

发起方
Institut de cancérologie Strasbourg Europe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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