The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study: A Food-based Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 503
- 试验地点
- 5
- 主要终点
- Disease-free survival
研究概览
简要总结
The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.
详细描述
Men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (Stage I-III) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. Patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. The study center is located at the Department of Nutrition, University of Oslo, and patients are recruited from two hospitals within the South-Eastern Norway Regional Health Authority. Primary outcomes are disease-free survival and overall survival. Secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •colorectal cancer (ICD10 C18-20) TNM Stage I-III
排除标准
- •TNM stage 0 or IV
研究组 & 干预措施
Intervention group
The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. Both groups are offered equal general advice of physical activity.
干预措施: Norwegian food based dietary guidelines (Other)
Control group
The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity.
干预措施: Norwegian food based dietary guidelines (Other)
结局指标
主要结局
Disease-free survival
时间窗: 5, 10 and 15 years
Disease-free survival (DFS) (events are defined as detection of local recurrence or metastasis or any second cancer or death from any cause)
Overall survival
时间窗: 10, 15 years
Overall survival (OS) (event is defined as death from any cause)
次要结局
- Total cancer-specific survival(up to 15 years)
- Time to recurrence(up to 15 years)
- CVD -free survival(up to 15 years)
- CRC-specific survival(up to 15 years)
- Inflammatory disease-specific survival(up to 15 years)
- Cardiovascular (CVD)-specific survival(up to 15 years)
- New morbidity of other diet-related chronic diseases(up to 15 years)
- Dietary intake and nutritional status(up to 15 years)
- Physical activity and function(up to 15 years)
- Nutrition biomarkers(up to 15 years)
- Body composition(up to 15 years)
- Biomarkers for inflammation and oxidative stress(up to 15 years)
- Transcription- and epigenetic profiles(up to 15 years)
- Anthropometric measures(up to 15 years)
- Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer(up to 15 years)
- Health related quality of life and fatigue(up to 15 years)
研究者
Rune Blomhoff
Professor
University of Oslo