title: The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial.
abstract: Colorectal cancer survivors are not only at risk for recurrent disease but also at increased risk of comorbidities such as other cancers, cardiovascular disease, diabetes, hypertension and functional decline. In this trial, we aim at investigating whether a diet in accordance with the Norwegian food-based dietary guidelines and focusing at dampening inflammation and oxidative stress will improve long-term disease outcomes and survival in colorectal cancer patients.
  
  
  
  This paper presents the study protocol of the Norwegian Dietary Guidelines and Colorectal Cancer Survival study. 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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier: NCT01570010 .
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Hege Berg
authors.initials: HB
authors.lastname: Henriksen
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Hanna
authors.initials: H
authors.lastname: Ræder
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Siv Kjølsrud
authors.initials: SK
authors.lastname: Bøhn
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Ingvild
authors.initials: I
authors.lastname: Paur
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Ane Sørlie
authors.initials: AS
authors.lastname: Kværner
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Siv Åshild
authors.initials: SÅ
authors.lastname: Billington
authors.affiliation: Department of Gastroenterological Surgery, Oslo University Hospital, Ullevål, Norway.|Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
authors.forename: Morten Tandberg
authors.initials: MT
authors.lastname: Eriksen
authors.affiliation: Department of Gastroenterological Surgery, Oslo University Hospital, Ullevål, Norway.
authors.forename: Gro
authors.initials: G
authors.lastname: Wiedsvang
authors.affiliation: National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Iris
authors.initials: I
authors.lastname: Erlund
authors.affiliation: Department of Digestive and Paediatric Surgery, Akershus University Hospital, Lørenskog, Norway.
authors.forename: Arne
authors.initials: A
authors.lastname: Færden
authors.affiliation: Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Marit Bragelien
authors.initials: MB
authors.lastname: Veierød
authors.affiliation: Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
authors.forename: Manuela
authors.initials: M
authors.lastname: Zucknick
authors.affiliation: Institute of Clinical Medicine, University of Oslo, Oslo, Norway.|Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Sigbjørn
authors.initials: S
authors.lastname: Smeland
authors.affiliation: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway. rune.blomhoff@medisin.uio.no.|Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway. rune.blomhoff@medisin.uio.no.
authors.forename: Rune
authors.initials: R
authors.lastname: Blomhoff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000178:diet therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000517:prevention & control*; D009664:Norway; D018384:Oxidative Stress; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome
keywords: Antioxidant-rich foods; Cardiovascular disease-free survival; Colorectal cancer; Comorbidity; Disease-free survival; Food-based dietary guidelines; Inflammation; Overall survival; Oxidative stress; Time to recurrence