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WithdrawnNCT00846313ColErnUpdated Dec 29, 2023

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

An interventional study of Individual dietary counseling. in Colorectal Neoplasm, sponsored by Norwegian University of Science and Technology. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Study was stopped due to lack of resources (clinical dietitians)
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasm

Keywords

  • Dietary intake
  • Dietary counseling
  • Weight loss
  • Body composition
  • Resting energy expenditure
  • Quality of life
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cognitive reduction
  • confusion
  • not able to answer questionaire
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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.

  • No intervention
    Control

Interventions

  • OtherIndividual 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.

    Also known as: Dietary intervention.

06

What researchers measure

Primary outcomes

  1. Body weight

    Time frame: 2 year

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00846313
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Feb 18, 2009
Start date
Dec 2003
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Dec 29, 2023

Study contacts

Lene Thoresen, MSc
principal investigator · St. Olavs Hospital, NTNU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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