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Fish Oil and EPO in Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Fish oil + EPO
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Military medical academyRecruiting
  • University of Belgrade

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in disease status
Remission, stable disease or progression
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2018
Last Updated
November 2, 2022
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT03516253
Brief Title
Fish Oil and EPO in Breast Cancer
Official Title
Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil + EPO
Intervention Description
Supplementation with both fish oil and EPO
Primary Outcome Measure Information:
Title
Change in disease status
Description
Remission, stable disease or progression
Time Frame
Baseline, 3 months, 1 year
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 3 months, 1 year
Secondary Outcome Measure Information:
Title
Changes in nutritional status
Description
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Time Frame
Baseline, 3 months, 1 year
Title
Changes in lipid profiles
Description
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Time Frame
Baseline, 3 months, 1 year
Title
Changes in plasma fatty acids profiles
Description
Changes in plasma fatty acids profiles from baseline to endpoint
Time Frame
Baseline, 3 months, 1 year
Title
Changes in interleukins
Description
Changes in interleukins (IL)-6, 8,10 and TNF alpha from baseline to endpoint
Time Frame
Baseline, 3 months, 1 year
Title
Changes in activity of superoxide dismutase.
Description
Measures of activity of superoxide dismutase.
Time Frame
Baseline, 3 months, 1 year
Title
Changes in activity of catalase.
Description
Measures of activity of catalase.
Time Frame
Baseline, 3 months, 1 year
Title
Changes in activity of glutathion peroxidase.
Description
Measures of activity of glutathion peroxidase.
Time Frame
Baseline, 3 months, 1 year
Title
Changes in activity of glutathion reductase.
Description
Measures of activity of glutathion reductase.
Time Frame
Baseline, 3 months, 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Military medical academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Predrag Krstic, MD
Phone
653618461
Ext
+381
Email
vesna.vucic.imr@gmail.com
First Name & Middle Initial & Last Name & Degree
Aleksandra Arsic, PhD
Phone
605888553
Ext
+381
Email
aleksandraarsicimi@gmail.com
Facility Name
University of Belgrade
City
Belgrade
ZIP/Postal Code
11129
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Arsic, PhD
Email
aleksandraarsicimi@gmail.com
First Name & Middle Initial & Last Name & Degree
Vesna Vucic, PhD
Email
vesna.vucic.imr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fish Oil and EPO in Breast Cancer

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