Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors (CRC-NORDIET)

University of Oslo

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Other: Norwegian food based dietary guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT01570010

CRC-NORDIET study

2011/836 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 503 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• TNM stage 0 or IV

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Norwegian food based dietary guidelines

Control group

Other group

Description:

The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity.

Treatment:

Other: Norwegian food based dietary guidelines