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

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ClinicalTrials.gov Identifier: NCT00846313
Recruitment Status : Withdrawn (Study was stopped due to lack of resources (clinical dietitians))
First Posted : February 18, 2009
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Neoplasm Other: Individual dietary counseling. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Study of Dietary Counseling for Patients With Colorectal Cancer.
Study Start Date : December 2003
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Body weight [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 2 year ]
  2. Quality of life [ Time Frame: 2 years ]
  3. Oncologic treatment [ Time Frame: 2 years ]
  4. Dietary intake [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846313


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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00846313     History of Changes
Other Study ID Numbers: 2002.127
10641 ( Other Identifier: The Data Inspectorate )
03/05111 ( Other Identifier: Biobank )
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases