PDF(Pubmed)
Abstract：
BACKGROUND: An underlying cause of solid tumor resistance to chemotherapy treatment is diminished tumor blood supply, which leads to a hypoxic microenvironment, dependence on anaerobic energy metabolism, and impaired delivery of intravenous treatments. Preclinical data suggest that dietary strategies of caloric restriction and low-carbohydrate intake can inhibit glycolysis, while acute exercise can transiently enhance blood flow to the tumor and reduce hypoxia. The Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer (DREAM) study will compare the effects of a short-term, 50% calorie-restricted and ketogenic diet combined with aerobic exercise performed during intravenous chemotherapy treatment to usual care on changes in tumor burden, treatment side effects, and quality of life.
METHODS: Fifty patients with measurable metastases and primary breast cancer starting a new line of intravenous chemotherapy will be randomly assigned to usual care or the combined diet and exercise intervention. Participants assigned to the intervention group will be provided with food consisting of 50% of measured calorie needs with 80% of calories from fat and ≤ 10% from carbohydrates for 48-72 h prior to each chemotherapy treatment and will perform 30-60 min of moderate-intensity cycle ergometer exercise during each chemotherapy infusion, for up to six treatment cycles. The diet and exercise durations will be adapted for each chemotherapy protocol. Tumor burden will be assessed by change in target lesion size using axial computed tomography (primary outcome) and magnetic resonance imaging (MRI)-derived apparent diffusion coefficient (secondary outcome) after up to six treatments. Tertiary outcomes will include quantitative MRI markers of treatment toxicity to the heart, thigh skeletal muscle, and liver, and patient-reported symptoms and quality of life. Exploratory outcome measures include progression-free and overall survival.
CONCLUSIONS: The DREAM study will test a novel, short-term diet and exercise intervention that is targeted to mechanisms of tumor resistance to chemotherapy. A reduction in lesion size is likely to translate to improved cancer outcomes including disease progression and overall survival. Furthermore, a lifestyle intervention may empower patients with metastatic breast cancer by actively engaging them to play a key role in their treatment.
BACKGROUND: ClinicalTrials.gov, NCT03795493 , registered 7 January, 2019.
METHODS: Fifty patients with measurable metastases and primary breast cancer starting a new line of intravenous chemotherapy will be randomly assigned to usual care or the combined diet and exercise intervention. Participants assigned to the intervention group will be provided with food consisting of 50% of measured calorie needs with 80% of calories from fat and ≤ 10% from carbohydrates for 48-72 h prior to each chemotherapy treatment and will perform 30-60 min of moderate-intensity cycle ergometer exercise during each chemotherapy infusion, for up to six treatment cycles. The diet and exercise durations will be adapted for each chemotherapy protocol. Tumor burden will be assessed by change in target lesion size using axial computed tomography (primary outcome) and magnetic resonance imaging (MRI)-derived apparent diffusion coefficient (secondary outcome) after up to six treatments. Tertiary outcomes will include quantitative MRI markers of treatment toxicity to the heart, thigh skeletal muscle, and liver, and patient-reported symptoms and quality of life. Exploratory outcome measures include progression-free and overall survival.
CONCLUSIONS: The DREAM study will test a novel, short-term diet and exercise intervention that is targeted to mechanisms of tumor resistance to chemotherapy. A reduction in lesion size is likely to translate to improved cancer outcomes including disease progression and overall survival. Furthermore, a lifestyle intervention may empower patients with metastatic breast cancer by actively engaging them to play a key role in their treatment.
BACKGROUND: ClinicalTrials.gov, NCT03795493 , registered 7 January, 2019.
摘要：
背景：实体瘤化疗耐药的根本原因是肿瘤血液供应减少，导致缺氧的微环境，依赖厌氧能量代谢，和静脉治疗的传递受损。临床前数据表明，热量限制和低碳水化合物摄入的饮食策略可以抑制糖酵解，而急性运动可以短暂增加肿瘤的血流量，减少缺氧。转移性乳腺癌（DREAM）的饮食限制和运动诱导的适应研究将比较短期，在静脉化疗治疗期间进行50％热量限制和生酮饮食结合有氧运动，以常规护理改变肿瘤负担，治疗副作用，和生活质量。
方法：50名开始新的静脉化疗的可测量转移和原发性乳腺癌患者将被随机分配到常规护理或联合饮食和运动干预。在每次化疗前48-72小时，分配到干预组的参与者将获得由50％的测量卡路里需求组成的食物，其中80％的卡路里来自脂肪，≤10％来自碳水化合物，并将在每次化疗输注期间进行30-60分钟的中等强度周期测功机锻炼。多达六个治疗周期。饮食和运动持续时间将适应每个化疗方案。肿瘤负荷将通过使用轴向计算机断层扫描（主要结果）和磁共振成像（MRI）得出的表观扩散系数（次要结果）的目标病变大小的变化进行评估。三级结果将包括对心脏的治疗毒性的定量MRI标记，大腿骨骼肌,还有肝脏,以及患者报告的症状和生活质量。探索性结果指标包括无进展生存期和总生存期。
结论：DREAM研究将测试一种新颖的，针对肿瘤化疗耐药机制的短期饮食和运动干预。病变大小的减少可能会转化为改善的癌症结果，包括疾病进展和总生存期。此外，生活方式干预可能使转移性乳腺癌患者积极参与他们在治疗中发挥关键作用.
背景：ClinicalTrials.gov，NCT03795493,1月7日登记,2019.
方法：50名开始新的静脉化疗的可测量转移和原发性乳腺癌患者将被随机分配到常规护理或联合饮食和运动干预。在每次化疗前48-72小时，分配到干预组的参与者将获得由50％的测量卡路里需求组成的食物，其中80％的卡路里来自脂肪，≤10％来自碳水化合物，并将在每次化疗输注期间进行30-60分钟的中等强度周期测功机锻炼。多达六个治疗周期。饮食和运动持续时间将适应每个化疗方案。肿瘤负荷将通过使用轴向计算机断层扫描（主要结果）和磁共振成像（MRI）得出的表观扩散系数（次要结果）的目标病变大小的变化进行评估。三级结果将包括对心脏的治疗毒性的定量MRI标记，大腿骨骼肌,还有肝脏,以及患者报告的症状和生活质量。探索性结果指标包括无进展生存期和总生存期。
结论：DREAM研究将测试一种新颖的，针对肿瘤化疗耐药机制的短期饮食和运动干预。病变大小的减少可能会转化为改善的癌症结果，包括疾病进展和总生存期。此外，生活方式干预可能使转移性乳腺癌患者积极参与他们在治疗中发挥关键作用.
背景：ClinicalTrials.gov，NCT03795493,1月7日登记,2019.
