Fish Oil and EPO in Breast Cancer

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: Breast Cancer
• Intervention / Treatment: Dietary supplement: Fish oil + EPO

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

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Military Medical Academy
    • Contact: Predrag Krstic, MD; Phone Number: +381 653618461; Email: vesna.vucic.imr@gmail.com
    • Contact: Aleksandra Arsic, PhD; Phone Number: +381 605888553; Email: aleksandraarsicimi@gmail.com
  • Belgrade, Serbia, 11129
    • Not yet recruiting
    • University of Belgrade
    • Contact: Aleksandra Arsic, PhD; Email: aleksandraarsicimi@gmail.com
    • Contact: Vesna Vucic, PhD; Email: vesna.vucic.imr@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Remission, stable disease or progression	Baseline, 3 months, 1 year
Change in quality of life	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	Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint	Baseline, 3 months, 1 year
Changes in lipid profiles	Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint	Baseline, 3 months, 1 year
Changes in plasma fatty acids profiles	Changes in plasma fatty acids profiles from baseline to endpoint	Baseline, 3 months, 1 year
Changes in interleukins	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.	Measures of activity of superoxide dismutase.	Baseline, 3 months, 1 year
Changes in activity of catalase.	Measures of activity of catalase.	Baseline, 3 months, 1 year
Changes in activity of glutathion peroxidase.	Measures of activity of glutathion peroxidase.	Baseline, 3 months, 1 year
Changes in activity of glutathion reductase.	Measures of activity of glutathion reductase.	Baseline, 3 months, 1 year

Collaborators and Investigators

• Sponsor: University of Belgrade

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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