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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
503
several means will be applied to guide participarts to cohere to the dietary guidelines including access to clinical nutritionists, free food, food discounts, cooking courses, cookbook/recipies, study website, organized physical activity, etc
Akershus University Hospital
Lørenskog, Norway
University of Oslo
Oslo, Norway
Oslo University Hospital
Oslo, Norway
Disease-free survival
Disease-free survival (DFS) (events are defined as detection of local recurrence or metastasis or any second cancer or death from any cause)
Time frame: 5, 10 and 15 years
Overall survival
Overall survival (OS) (event is defined as death from any cause)
Time frame: 5, 10 and 15 years
Time to recurrence
Events are defined as detection of local recurrence or metastasis
Time frame: up to 15 years
CVD -free survival
Events of CVD (ICD-10; chapter I) or death from any cause
Time frame: up to 15 years
CRC-specific survival
death due to CRC
Time frame: up to 15 years
Total cancer-specific survival
death due to CRC or any other cancer
Time frame: up to 15 years
Inflammatory disease-specific survival
death due to inflammatory disease
Time frame: up to 15 years
Cardiovascular (CVD)-specific survival
death due to CVD
Time frame: up to 15 years
New morbidity of other diet-related chronic diseases
e.g. ischemic coronary heart disease, cerebrovascular disease, thromboembolic disease, type 2 diabetes, obesity, hypertension and chronic obstructive pulmonary disease
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Time frame: up to 15 years
Dietary intake and nutritional status
Questionnaires, food records, clinical consultation
Time frame: up to 15 years
Physical activity and function
Questionnaires, arm band, physical tests
Time frame: up to 15 years
Nutrition biomarkers
e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc
Time frame: up to 15 years
Body composition
DXA, CT, BIA
Time frame: up to 15 years
Anthropometric measures
eg weight, waist and hip circumference
Time frame: up to 15 years
Biomarkers for inflammation and oxidative stress
e.g. isoprostanes, cytokines
Time frame: up to 15 years
Transcription- and epigenetic profiles
sequencing and arrays
Time frame: up to 15 years
Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer
e.g. blood pressure, total/LDLcholesterol, HbA1c, CRP, IL-6, IL-10, TNFα
Time frame: up to 15 years
Health related quality of life and fatigue
Questionnaires
Time frame: up to 15 years