The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- University of Oslo
- Enrollment
- 503
- Locations
- 3
- Primary Endpoint
- Disease-free survival
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rune Blomhoff
Professor
University of Oslo
Eligibility Criteria
Inclusion Criteria
- •colorectal cancer (ICD10 C18-20) TNM Stage I-III
Exclusion Criteria
- •TNM stage 0 or IV
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 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
Time Frame: 10, 15 years
Overall survival (OS) (event is defined as death from any cause)
Secondary Outcomes
- 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)