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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Phase
Colorectal Neoplasm
 Other: Individual dietary counseling.
 Phase 3

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 250
Study Start Date: December 2003
Estimated Study Completion Date: June 2009
Primary Completion Date: March 2008 (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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive reduction
  • confusion
  • not able to answer questionaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846313

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

No publications provided

Responsible Party: Lene Thoresen, RD, MSc, St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00846313     History of Changes
Other Study ID Numbers: 2002.127, 10641 (The Data Inspectorate), Biobank 03/05111
Study First Received: February 16, 2009
Last Updated: February 16, 2009
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:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 26, 2012