Fish Oil and EPO in Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Fish oil + EPO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Supplementation with both fish oil and EPO<br>|
| No Intervention: Control group<br>Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch. | |

What is the study measuring?
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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 |