Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D? (ColErn)

This study has been withdrawn prior to enrollment.
(Study was stopped due to lack of resources (clinical dietitians))
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: February 16, 2009
Last updated: April 7, 2015
Last verified: April 2015
The purpose of this randomised intervention study is to investigate to what degree patients with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic treatment and quality of life.

Condition Intervention
Colorectal Neoplasm
Other: Individual dietary counseling.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Study of Dietary Counseling for Patients With Colorectal Cancer.

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Body weight [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Oncologic treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Dietary intake [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2003
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary counseling
Patients receive dietary advice at an individual level and are offered contact with clinical dietitian every second week if necessary.
Other: Individual dietary counseling.
Dietary advice based on individual requirement and symptom burden. Dietary intervention may be dietary advice, energy rich foods and drinks, oral nutritional supplements, appetite stimulation with Megestrol Acetate, enteral or parenteral nutrition.
Other Name: Dietary intervention.
No Intervention: Control


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • metastatic colorectal cancer
  • histological verified cancer
  • age >18 years

Exclusion Criteria:

  • cognitive reduction
  • confusion
  • not able to answer questionaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00846313

Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Lene Thoresen, MSc St. Olavs Hospital, NTNU
  More Information

Responsible Party: Norwegian University of Science and Technology Identifier: NCT00846313     History of Changes
Other Study ID Numbers: 2002.127  10641  03/05111 
Study First Received: February 16, 2009
Last Updated: April 7, 2015
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Dietary intake
Dietary counseling
Weight loss
Body composition
Resting energy expenditure
Quality of life

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 05, 2016