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Fish Oil and EPO in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516253
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aleksandra Arsic, University of Belgrade

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Fish oil + EPO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study is a parallel, randomized, double blind, controlled, 3-months supplementation, investigating health effects of dietary intake of fish oil and EPO, in patients with breast cancer undergoing chemotherapy.

At the beginning of the study, all patients received nutritional counseling, where half of the study subjects are randomly assigned to a treatment arm with fish oil and EPO, or control arm with olive oil as placebo. Treatment arm is provided with 2 gel capsules of fish oil and 3 gel capsules of EPO (400 mg eicosapentaenoic acid, 600 mg docosahexaenoic acid and 351 mg gamma-linolenic acid). Control arm will consume 5 gel capsules of 1g of olive oil.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Basic Science
Official Title: Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fish oil

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: Olive oil (5 gel capsules, each 1g olive oil), 3 months with lunch.



Primary Outcome Measures :
  1. Change in disease status [ Time Frame: Baseline, 3 months, 1 year ]
    Remission, stable disease or progression

  2. 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.


Secondary Outcome Measures :
  1. Changes in nutritional status [ Time Frame: Baseline, 3 months, 1 year ]
    Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint

  2. Changes in lipid profiles [ Time Frame: Baseline, 3 months, 1 year ]
    Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint

  3. Changes in plasma fatty acids profiles [ Time Frame: Baseline, 3 months, 1 year ]
    Changes in plasma fatty acids profiles from baseline to endpoint

  4. Changes in interleukins [ Time Frame: Baseline, 3 months, 1 year ]
    Changes in interleukins (IL)-1, 4, 6 and 10 from baseline to endpoint

  5. Changes in activity of superoxide dismutase. [ Time Frame: Baseline, 3 months, 1 year ]
    Measures of activity of superoxide dismutase.

  6. Changes in activity of catalase. [ Time Frame: Baseline, 3 months, 1 year ]
    Measures of activity of catalase.

  7. Changes in activity of glutathion peroxidase. [ Time Frame: Baseline, 3 months, 1 year ]
    Measures of activity of glutathion peroxidase.

  8. Changes in activity of glutathion reductase. [ Time Frame: Baseline, 3 months, 1 year ]
    Measures of activity of glutathion reductase.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516253


Locations
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Serbia
Military medical academy Recruiting
Belgrade, Serbia, 11000
Contact: Predrag Krstic, MD    653618461 ext +381    vesna.vucic.imr@gmail.com   
Contact: Aleksandra Arsic, PhD    605888553 ext +381    aleksandraarsicimi@gmail.com   
University of Belgrade Not yet recruiting
Belgrade, Serbia, 11129
Contact: Aleksandra Arsic, PhD       aleksandraarsicimi@gmail.com   
Contact: Vesna Vucic, PhD       vesna.vucic.imr@gmail.com   
Sponsors and Collaborators
University of Belgrade
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Responsible Party: Aleksandra Arsic, Research Associate Professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT03516253    
Other Study ID Numbers: VMA-253-18
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases