Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
研究概览
简要总结
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.
详细描述
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.
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
- •Breast cancer (stade I to III)
- •Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment
排除标准
- •History of cancer
- •Known chronic pathology
- •Pacemaker
- •Contraindication to the evaluation of the physical condition
- •Contraindication to the local anesthesia for the muscle micro-biopsy
- •Breastfeeding or pregnant woman
研究组 & 干预措施
Epirubicin-cyclophosphamide
Woman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide
干预措施: Epirubicin-cyclophosphamide (Drug)
Paclitaxel
Woman with early breast cancer receiving a first cycle of paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
时间窗: Before and 4 days after the chemotherapy
Change From Baseline in Western Blots measurements of protein expression levels
次要结局
- Investigate the acute effect of chemotherapy administration on structural alterations(Before and 4 days after the chemotherapy)
- Investigate the acute effect of chemotherapy administration on satellite cells(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss(Before and 4 days after the chemotherapy)
- Investigate the acute effect of chemotherapy administration on inflammation(Before and 4 days after the chemotherapy)
- Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis(Before and 4 days after the chemotherapy)
- Investigate the acute effect of chemotherapy administration on fatty infiltrations(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level(Before and 4 days after the chemotherapy)
- .Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity(Before and 4 days after the chemotherapy)
- Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life(Before and 4 days after the chemotherapy)