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

Colorectal Cancer Clinical Trial

— CRC-NORDIET  

Official title:

The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01570010
• Other study ID #: CRC-NORDIET study
• Secondary ID: 2011/836
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: December 31, 2040

Study information

• Verified date: March 2022
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 503
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• TNM stage 0 or IV

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Norwegian food based dietary guidelines
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

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo
Norway	University of Oslo	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
University of Oslo	Finnish Institute for Health and Welfare, Norwegian Cancer Society, Oslo University Hospital, The Research Council of Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Alavi DH, Henriksen HB, Lauritzen PM, Kværner AS, Sakinis T, Langleite TM, Henriksen C, Bøhn 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 — View Citation

Henriksen C, Paur I, Pedersen A, Kværner AS, Ræder H, Henriksen HB, Bøhn 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: 10.10 — View Citation

Henriksen HB, Berntsen S, Paur I, Zucknick M, Skjetne AJ, Bøhn 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 — View Citation

Henriksen HB, Carlsen MH, Paur I, Berntsen S, Bøhn SK, Skjetne AJ, Kværner 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 colorec — View Citation

Henriksen HB, Ræder H, Bøhn SK, Paur I, Kværner AS, Billington SÅ, Eriksen MT, Wiedsvang G, Erlund I, Færden A, Veierød MB, Zucknick M, Smeland S, Blomhoff R. The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-base — View Citation

Outcome

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