The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer

January 6, 2021 updated by: Jens Rikardt Andersen, University of Copenhagen

Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.

The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary outcomes:

  • Weight
  • Physical function
  • Hand-grip strength

Secondary outcomes:

  • Quality of life
  • Mid-upperarm circumference
  • Incorporation of n-3 PUFAs into cell membranes

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100 OE
        • Departmen of Oncology, Rigshospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years
  • Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen

Exclusion Criteria:

  • < 18 years
  • Patients in palliative care
  • patients with haemophilia
  • Patiens in treatment of anti-coagulation
  • Patients with genetic hyperkolesterolemia
  • Pre-dialytic patients (GFR<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Nutritional supplement without fish oil
Dietary supplement: Placebo
Placebo
ACTIVE_COMPARATOR: Fish oil
Nutritional supplement with fish oil
Dietary supplement: Fish Oil
8 weeks, 2.2 G EPA/day
Other Names:
  • Smart Fish - cancer cachexia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 8 weeks
Difference in weight (kg) from inclusion to 8 week status
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of Life score
Time Frame: 8 weeks
score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)
8 weeks
Performance status - common daily abilities
Time Frame: 8 weeks
combined scale - score - ADL
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (ACTUAL)

January 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2014-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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