Fish Oil and EPO in Breast Cancer

November 2, 2022 updated by: Aleksandra Arsic, University of Belgrade

Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer

Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Fish oil and evening primrose oil provide a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer (BC) is leading cancer in women. As most of the cancers, it is characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with BC have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.

Fish oil is the richest source of anti-inflammatory n-3 PUFAs. Evening primrose oil (EPO) is rich in 18:3 n-6, the only n-6 fatty acid with an anti-inflammatory effect. Dietary intake of fish oil or EPO has been shown to decrease inflammation and improve PUFAs status in patients with cancers. However, it is not known what is the effect of combined EPO and fish oil in BC patients.

The study design is double-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Study Type

Interventional

Enrollment (Anticipated)

60

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

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

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed breast cancer,
  • Clinical Stadium III and IV,
  • Patients able to understand requirements of the study and provide written informed consent-

Exclusion Criteria:

  • Previous radio- or chemotherapy
  • Other serious chronic diseases
  • Statin therapy
  • Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Dietary Supplement: Fish oil + EPO. Fish oil (2 gel capsules, each 1g fish oil with 500 mg EPA+DHA) and EPO (Evening primrose oil 3 gel capsules with 117 mg GLA), 3 months with lunch.
Dietary supplement: Fish oil + EPO
Supplementation with both fish oil and EPO
No Intervention: Control group
Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease status
Time Frame: Baseline, 3 months, 1 year
Remission, stable disease or progression
Baseline, 3 months, 1 year
Change in quality of life
Time Frame: Baseline, 3 months, 1 year
Assessed by standardized questionnaires, scale 1-4 (1-not at all, 2- a little, 3 - quite a bit, 4- very much), higher value represents worse outcome.
Baseline, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in nutritional status
Time Frame: Baseline, 3 months, 1 year
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Baseline, 3 months, 1 year
Changes in lipid profiles
Time Frame: Baseline, 3 months, 1 year
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Baseline, 3 months, 1 year
Changes in plasma fatty acids profiles
Time Frame: Baseline, 3 months, 1 year
Changes in plasma fatty acids profiles from baseline to endpoint
Baseline, 3 months, 1 year
Changes in interleukins
Time Frame: Baseline, 3 months, 1 year
Changes in interleukins (IL)-6, 8,10 and TNF alpha from baseline to endpoint
Baseline, 3 months, 1 year
Changes in activity of superoxide dismutase.
Time Frame: Baseline, 3 months, 1 year
Measures of activity of superoxide dismutase.
Baseline, 3 months, 1 year
Changes in activity of catalase.
Time Frame: Baseline, 3 months, 1 year
Measures of activity of catalase.
Baseline, 3 months, 1 year
Changes in activity of glutathion peroxidase.
Time Frame: Baseline, 3 months, 1 year
Measures of activity of glutathion peroxidase.
Baseline, 3 months, 1 year
Changes in activity of glutathion reductase.
Time Frame: Baseline, 3 months, 1 year
Measures of activity of glutathion reductase.
Baseline, 3 months, 1 year

Collaborators and Investigators

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

Sponsor

University of Belgrade

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)

February 20, 2019

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMA-253-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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