Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer

November 21, 2018 updated by: Jens Rikardt Andersen, University of Copenhagen

Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.

Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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
        • Rigshospitalet

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
  • Not terminally ill
  • Subjects must be18 years of age (or older)

Exclusion Criteria:

  • Subjects who do not read/speak/understand Danish
  • Familial hypercholesterolemia
  • Predialytic patients (GFR < 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)
  • Use of blood thinners
  • Bleeder's disease

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capsules
Dietary Supplement: Möllers Omega-3 Ekstra Sterk
Dietary supplement: Möllers Omega-3 Ekstra Sterk
ACTIVE_COMPARATOR: Drink
Dietary Supplement: Nutrifriend Cachexia
Dietary supplement: Nutrifriend Cachexia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 4 weeks
Number of Capsules and bottles counted
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythrocyte concentration of EPA
Time Frame: 4 weeks
Concentration measured on isolated erythrocytes
4 weeks

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Collaborators

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

May 18, 2015

Primary Completion (ACTUAL)

September 25, 2017

Study Completion (ACTUAL)

November 10, 2018

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H-15000693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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