NCT00846313

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

5.2 years

First QC Date

February 16, 2009

Last Update Submit

December 28, 2023

Conditions

Colorectal Neoplasm

Keywords

Dietary intakeDietary counselingWeight lossBody compositionResting energy expenditureQuality of life

Outcome Measures

Primary Outcomes (1)

  • Body weight

    2 year

Secondary Outcomes (4)

  • Body composition

    2 year

  • Quality of life

    2 years

  • Oncologic treatment

    2 years

  • Dietary intake

    2 years

Study Arms (2)

Dietary counseling

ACTIVE COMPARATOR

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

Other: Individual dietary counseling.

Control

NO INTERVENTION

Interventions

Individual dietary counseling.OTHER

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.
Dietary counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • cognitive reduction
  • confusion
  • not able to answer questionaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsWeight Loss

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Lene Thoresen, MSc

    St. Olavs Hospital, NTNU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

December 1, 2003

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 29, 2023

Record last verified: 2023-12