Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D? (ColErn)
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.
|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.|
- Body weight [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||June 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846313
|Principal Investigator:||Lene Thoresen, MSc||St. Olavs Hospital, NTNU|