Fish Oil and EPO in Breast Cancer

NCT03516253 | Unknown

• 1 other identifier: VMA-253-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes in nutritional status

  Baseline, 3 months, 1 year

• Changes in lipid profiles

  Baseline, 3 months, 1 year

• Changes in plasma fatty acids profiles

  Baseline, 3 months, 1 year

• Changes in interleukins

  Baseline, 3 months, 1 year

• Changes in activity of superoxide dismutase.

  Baseline, 3 months, 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch.

Interventions

Fish oil + EPO DIETARY_SUPPLEMENT

Supplementation with both fish oil and EPO

Intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (2)

Military medical academy

Belgrade, 11000, Serbia

RECRUITING

University of Belgrade

Belgrade, 11129, Serbia

NOT YET RECRUITING

Related Publications (1)

• Arsic A, Krstic P, Paunovic M, Nedovic J, Jakovljevic V, Vucic V. Anti-inflammatory effect of combining fish oil and evening primrose oil supplementation on breast cancer patients undergoing chemotherapy: a randomized placebo-controlled trial. Sci Rep. 2023 Apr 20;13(1):6449. doi: 10.1038/s41598-023-28411-8.

  PMID: 37081029 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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 mineral 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 mineral oil.

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: May 4, 2018
• Study Start: February 20, 2019
• Primary Completion: December 20, 2023
• Study Completion: June 20, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)