Clinical trial NCT01570010: Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors
Official title: The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Finnish Institute for Health and Welfare
name: University Hospital, Akershus
name: Norwegian Cancer Society
name: The Research Council of Norway
First posted: 2012-04-04
Enrollment: 503
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized clinical trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* TNM stage 0 or IV

Primary outcomes:
measure: Disease-free survival
timeFrame: 5, 10 and 15 years
measure: Overall survival
timeFrame: 10, 15 years
Secondary outcomes:
measure: Time to recurrence
timeFrame: up to 15 years
measure: CVD -free survival
timeFrame: up to 15 years
measure: CRC-specific survival
timeFrame: up to 15 years
measure: Total cancer-specific survival
timeFrame: up to 15 years
measure: Inflammatory disease-specific survival
timeFrame: up to 15 years
measure: Cardiovascular (CVD)-specific survival
timeFrame: up to 15 years
measure: New morbidity of other diet-related chronic diseases
timeFrame: up to 15 years
measure: Dietary intake and nutritional status
timeFrame: up to 15 years
measure: Physical activity and function
timeFrame: up to 15 years
measure: Nutrition biomarkers
timeFrame: up to 15 years
measure: Body composition
timeFrame: up to 15 years
measure: Anthropometric measures
timeFrame: up to 15 years
measure: Biomarkers for inflammation and oxidative stress
timeFrame: up to 15 years
measure: Transcription- and epigenetic profiles
timeFrame: up to 15 years
measure: Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer
timeFrame: up to 15 years
measure: Health related quality of life and fatigue
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: University of Oslo
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Rune Blomhoff, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henriksen HB, Raeder H, Bohn SK, Paur I, Kvaerner AS, Billington SA, Eriksen MT, Wiedsvang G, Erlund I, Faerden A, Veierod MB, Zucknick M, Smeland S, Blomhoff R. The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial. BMC Cancer. 2017 Jan 30;17(1):83. doi: 10.1186/s12885-017-3072-4.
citation: Henriksen C, Paur I, Pedersen A, Kvaerner AS, Raeder H, Henriksen HB, Bohn SK, Wiedswang G, Blomhoff R. Agreement between GLIM and PG-SGA for diagnosis of malnutrition depends on the screening tool used in GLIM. Clin Nutr. 2022 Feb;41(2):329-336. doi: 10.1016/j.clnu.2021.12.024. Epub 2021 Dec 18.
citation: Alavi DH, Henriksen HB, Lauritzen PM, Kvaerner AS, Sakinis T, Langleite TM, Henriksen C, Bohn SK, Paur I, Wiedswang G, Smeland S, Blomhoff R. Quantification of adipose tissues by Dual-Energy X-Ray Absorptiometry and Computed Tomography in colorectal cancer patients. Clin Nutr ESPEN. 2021 Jun;43:360-368. doi: 10.1016/j.clnesp.2021.03.022. Epub 2021 Apr 15.
citation: Henriksen HB, Berntsen S, Paur I, Zucknick M, Skjetne AJ, Bohn SK, Henriksen C, Smeland S, Carlsen MH, Blomhoff R. Validation of two short questionnaires assessing physical activity in colorectal cancer patients. BMC Sports Sci Med Rehabil. 2018 May 29;10:8. doi: 10.1186/s13102-018-0096-2. eCollection 2018.
citation: Henriksen HB, Carlsen MH, Paur I, Berntsen S, Bohn SK, Skjetne AJ, Kvaerner AS, Henriksen C, Andersen LF, Smeland S, Blomhoff R. Relative validity of a short food frequency questionnaire assessing adherence to the Norwegian dietary guidelines among colorectal cancer patients. Food Nutr Res. 2018 Feb 22;62. doi: 10.29219/fnr.v62.1306. eCollection 2018.