背景:几十年来,蒽环类药物化疗一直是乳腺癌辅助治疗的主流。虽然有效,蒽环类药物使长期乳腺癌幸存者面临后期影响的风险,如心肺功能降低和心血管疾病风险增加。先前的研究表明,运动训练对心肺健康有益,但是运动对心肺健康限制因素的影响,心血管危险因素,患者报告的长期幸存者结局不太清楚.以前接受乳腺癌治疗是否会调节运动的效果也是未知的。
目的:CAUSE(心血管幸存者运动)试验的主要目的是研究有氧运动对蒽环类药物治疗的长期乳腺癌幸存者的心肺适应性的影响。次要目的是检查运动训练对心肺健康限制因素的影响,心血管危险因素,和患者报告的结果,并比较基线值和运动训练的效果在相似年龄的女性和那些没有乳腺癌。第三个目标是研究有氧运动对主要和次要结果的24个月干预后影响。
方法:原因试验是一项双臂随机对照试验,140名长期乳腺癌幸存者,诊断后8-12年,被分配到为期5个月的非线性有氧运动计划,每周3次,或接受标准护理。70名没有癌症史的相似年龄的女性将接受相同的锻炼计划。以峰值耗氧量(VO2peak)测量的心肺适应性,VO2峰的限制因素(例如,心功能,肺功能,血红蛋白质量,血容量,和骨骼肌特征),心血管危险因素(例如,高血压,糖尿病,血脂异常,肥胖,身体活动水平,和吸烟状况),和患者报告的结果(例如,身体形象,疲劳,心理健康,和健康相关的生活质量)将在基线进行评估,干预后,干预后24个月。
结果:从2020年10月至2022年8月,共纳入209例患者,干预后评估于2023年1月完成。24个月的随访将于2025年2月完成。
结论:CAUSE试验的结果将为长期乳腺癌幸存者运动训练的潜在益处提供新的科学理解。
背景:ClinicalTrials.govNCT04307407;https://clinicaltrials.gov/ct2/show/NCT04307407。
UNASSIGNED:DERR1-10.2196/45244。
Anthracycline-based chemotherapy has been mainstay of adjuvant breast cancer therapy for decades. Although effective, anthracyclines place long-term breast cancer survivors at risk of late effects, such as reduced cardiorespiratory fitness and increased risk of cardiovascular disease. Previous research has shown beneficial effects of exercise training on cardiorespiratory fitness, but the effects of exercise on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes in long-term survivors are less clear. Whether previous exposure to breast cancer therapy modulates the effects of exercise is also unknown.
The primary aim of the CAUSE (Cardiovascular Survivors Exercise) trial is to examine the effect of aerobic exercise on cardiorespiratory fitness in anthracycline-treated long-term breast cancer survivors. Secondary aims are to examine effects of exercise training on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes, and to compare baseline values and effects of exercise training between similar-aged women with and those without prior breast cancer. A third aim is to examine the 24-month postintervention effects of aerobic exercise on primary and secondary outcomes.
The CAUSE trial is a 2-armed randomized controlled trial, where 140 long-term breast cancer survivors, 8-12 years post diagnosis, are assigned to a 5-month nonlinear aerobic exercise program with 3 weekly sessions or to standard care. Seventy similar-aged women with no history of cancer will undergo the same exercise program. Cardiorespiratory fitness measured as peak oxygen consumption (VO2peak), limiting factors for VO2peak (eg, cardiac function, pulmonary function, hemoglobin mass, blood volume, and skeletal muscle characteristics), cardiovascular risk factors (eg, hypertension, diabetes, dyslipidemia, obesity, physical activity level, and smoking status), and patient-reported outcomes (eg, body image, fatigue, mental health, and health-related quality of life) will be assessed at baseline, post intervention, and 24 months post intervention.
A total of 209 patients were included from October 2020 to August 2022, and postintervention assessments were completed in January 2023. The 24-month follow-up will be completed in February 2025.
The findings from the CAUSE trial will provide novel scientific understanding of the potential benefits of exercise training in long-term breast cancer survivors.
ClinicalTrials.gov NCT04307407; https://clinicaltrials.gov/ct2/show/NCT04307407.
DERR1-10.2196/45244.