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This study has been withdrawn prior to enrollment.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).)
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00846313
First received: February 16, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 16, 2009
February 16, 2009
December 2003
March 2008   (final data collection date for primary outcome measure)
Body weight [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?
A Randomised Study of Dietary Counseling for Patients With Colorectal Cancer.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colorectal Neoplasm
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.
  • Active Comparator: Dietary counseling
    Patients receive dietary advice at an individual level and are offered contact with clinical dietitian every second week if necessary.
    Intervention: Other: Individual dietary counseling.
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
250
June 2009
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive reduction
  • confusion
  • not able to answer questionaire
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00846313
2002.127, 10641 (The Data Inspectorate), Biobank 03/05111
No
Lene Thoresen, RD, MSc, St. Olavs Hospital
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Lene Thoresen, MSc St. Olavs Hospital, NTNU
Norwegian University of Science and Technology
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP