Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- handgrip strength
研究概览
简要总结
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
详细描述
Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.
Principal aim:
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Secondary aims:
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
- •Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm
排除标准
- •Not meeting all of the above.
结局指标
主要结局
handgrip strength
时间窗: Change from baseline to end of intervention (i.e., after 24 weeks)
handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
muscle dynamic strength
时间窗: Change from baseline to end of intervention (i.e., after 24 weeks)
Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
Cardiorespiratory fitness
时间窗: Change from baseline to end of intervention (i.e., after 24 weeks)
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
次要结局
- Body composition (fat mass)(Change from baseline to end of intervention (i.e., after 24 weeks))
- Body composition (lean body mass)(Change from baseline to end of intervention (i.e., after 24 weeks))
- Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])(Change from baseline to end of intervention (i.e., after 24 weeks))
研究者
Alejandro Lucia
Professor
Universidad Europea de Madrid