Effects of Heavy-load Resistance Training During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of changes in muscle fiber cross-sectional area
研究概览
简要总结
(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer.
详细描述
The aim of this study is to investigate the effects of heavy-load resistance training on muscle cellular outcomes in women with breast cancer undergoing (neo-)adjuvant chemotherapy.
More specifically, the investigators' objectives are to
- Investigate the effects of a heavy-load resistance training intervention on skeletal muscle fiber cross-sectional area.
- Investigate the effects of a heavy-load resistance training intervention on regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function.
- Investigate the effects of chemotherapy on skeletal muscle fiber cross-sectional area, regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function.
- Explore the effects of heavy-load resistance training on the expression levels of myokines.
This study is a two-armed randomized controlled trial with follow-up at six months. With this design, the investigators can study the main effect and interactions between factors (groups). Participants will be randomized to either an intervention group or a control group.
Participants recently diagnosed with breast cancer will be recruited from Uppsala University Hospital. Based on power calculations, 50 participants will be included. Data will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •women diagnosed with stage I-III breast cancer
- •literate in Swedish
- •scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of these treatments
排除标准
- •unable to perform basic activities of daily living
- •cognitive disorders or severe emotional instability
- •other disabling comorbidities that might hamper physical training (e.g. severe heart failure, chronic obstructive pulmonary disease, orthopedic conditions, and neurological disorders)
结局指标
主要结局
Assessment of changes in muscle fiber cross-sectional area
时间窗: From baseline to the 16 week time-point
Change from baseline in muscle fiber cross-sectional area at 16 weeks. Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers
次要结局
- Assessment of changes in satellite cell content in muscle fiber cross-sections(From baseline to the 16 week time-point and from baseline to 6-month follow-up)
- Assessment of changes in myonuclei content in muscle fiber cross-sections(From baseline to the 16 week time-point and from baseline to 6-month follow-up)
- Assessment of protein levels of regulators of muscle fiber size (proteins involved in muscle protein synthesis and protein degradation (e.i. mTOR, MuRF, S6K1, p70S6k)(From baseline to the 16 week time-point and from baseline to 6-month follow-up)
- Assessment of changes in myokines with potential anti-tumor effects(From baseline to the 16 week time-point and from baseline to the 6-month follow-up)
- Assessment of changes in muscle fiber cross-sectional area(From baseline to 6-month follow-up)
- Assessment of changes in protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, αB-crystalline, Hsp 60 and Hsp 70)(From baseline to the 16 week time-point and from baseline to the 6-month follow-up)
- Assessment of changes in protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HAD)(From baseline to the 16 week time-point and from baseline to the 6-month follow-up)
- Changes in muscle strength(From baseline to the 16 week time-point and from baseline to the 6-month follow-up)
- Cardiorespiratory fitness(From baseline to the 16 week time-point and from baseline to the 6-month follow-up)
研究者
Karin Nordin
Professor
Uppsala University