Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Norwegian food based dietary guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: colorectal cancer (ICD10 C18-20) TNM Stage I-III Exclusion Criteria: TNM stage 0 or IV

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Norwegian food based dietary guidelines<br>* 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<br>* Other names: Typisk norsk;|
| Other: Control group<br>The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. | Other: Norwegian food based dietary guidelines<br>* 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<br>* Other names: Typisk norsk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5, 10 and 15 years | 
| Overall survival | Overall survival (OS) (event is defined as death from any cause) | 10, 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence | Events are defined as detection of local recurrence or metastasis | up to 15 years | 
| CVD -free survival | Events of CVD (ICD-10; chapter I) or death from any cause | up to 15 years | 
| CRC-specific survival | death due to CRC | up to 15 years | 
| Total cancer-specific survival | death due to CRC or any other cancer | up to 15 years | 
| Inflammatory disease-specific survival | death due to inflammatory disease | up to 15 years | 
| Cardiovascular (CVD)-specific survival | death due to CVD | 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 | up to 15 years | 
| Dietary intake and nutritional status | Questionnaires, food records, clinical consultation | up to 15 years | 
| Physical activity and function | Questionnaires, arm band, physical tests | up to 15 years | 
| Nutrition biomarkers | e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc | up to 15 years | 
| Body composition | DXA, CT, BIA | up to 15 years | 
| Anthropometric measures | eg weight, waist and hip circumference | up to 15 years | 
| Biomarkers for inflammation and oxidative stress | e.g. isoprostanes, cytokines | up to 15 years | 
| Transcription- and epigenetic profiles | sequencing and arrays | 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 | up to 15 years | 
| Health related quality of life and fatigue | Questionnaires | up to 15 years |