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

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Norwegian food based dietary guidelines

• Registration Number: NCT01570010
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study Start: 2012-03-01
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-28
• Primary Completion: 2034-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• colorectal cancer (ICD10 C18-20) TNM Stage I-III

Exclusion Criteria

• TNM stage 0 or IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Norwegian food based dietary guidelines	The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity.
Intervention group	Norwegian food based dietary guidelines	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	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	10, 15 years	Overall survival (OS) (event is defined as death from any cause)

Secondary Outcome Measures

Name	Time	Method
Total cancer-specific survival	up to 15 years	death due to CRC or any other cancer
Time to recurrence	up to 15 years	Events are defined as detection of local recurrence or metastasis
CVD -free survival	up to 15 years	Events of CVD (ICD-10; chapter I) or death from any cause
CRC-specific survival	up to 15 years	death due to CRC
Inflammatory disease-specific survival	up to 15 years	death due to inflammatory disease
Cardiovascular (CVD)-specific survival	up to 15 years	death due to CVD
New morbidity of other diet-related chronic diseases	up to 15 years	e.g. ischemic coronary heart disease, cerebrovascular disease, thromboembolic disease, type 2 diabetes, obesity, hypertension and chronic obstructive pulmonary disease
Dietary intake and nutritional status	up to 15 years	Questionnaires, food records, clinical consultation
Physical activity and function	up to 15 years	Questionnaires, arm band, physical tests
Nutrition biomarkers	up to 15 years	e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc
Body composition	up to 15 years	DXA, CT, BIA
Anthropometric measures	up to 15 years	eg weight, waist and hip circumference
Biomarkers for inflammation and oxidative stress	up to 15 years	e.g. isoprostanes, cytokines
Transcription- and epigenetic profiles	up to 15 years	sequencing and arrays
Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer	up to 15 years	e.g. blood pressure, total/LDLcholesterol, HbA1c, CRP, IL-6, IL-10, TNFα
Health related quality of life and fatigue	up to 15 years	Questionnaires

Trial Locations

Locations (3)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

University of Oslo; 🇳🇴 Oslo, Norway