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

Primary Purpose

Colorectal Neoplasm

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual dietary counseling.
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasm focused on measuring Dietary intake, Dietary counseling, Weight loss, Body composition, Resting energy expenditure, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive reduction
  • confusion
  • not able to answer questionaire

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Dietary counseling

    Control

    Arm Description

    Patients receive dietary advice at an individual level and are offered contact with clinical dietitian every second week if necessary.

    Outcomes

    Primary Outcome Measures

    Body weight

    Secondary Outcome Measures

    Body composition
    Quality of life
    Oncologic treatment
    Dietary intake

    Full Information

    First Posted
    February 16, 2009
    Last Updated
    April 7, 2015
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    St. Olavs Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00846313
    Brief Title
    Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?
    Acronym
    ColErn
    Official Title
    A Randomised Study of Dietary Counseling for Patients With Colorectal Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was stopped due to lack of resources (clinical dietitians)
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    St. Olavs Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasm
    Keywords
    Dietary intake, Dietary counseling, Weight loss, Body composition, Resting energy expenditure, Quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dietary counseling
    Arm Type
    Active Comparator
    Arm Description
    Patients receive dietary advice at an individual level and are offered contact with clinical dietitian every second week if necessary.
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Individual dietary counseling.
    Other Intervention Name(s)
    Dietary intervention.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body weight
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Body composition
    Time Frame
    2 year
    Title
    Quality of life
    Time Frame
    2 years
    Title
    Oncologic treatment
    Time Frame
    2 years
    Title
    Dietary intake
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: metastatic colorectal cancer histological verified cancer age >18 years Exclusion Criteria: cognitive reduction confusion not able to answer questionaire
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lene Thoresen, MSc
    Organizational Affiliation
    St. Olavs Hospital, NTNU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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