Fish Oil and EPO in Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Dietary Supplement: Fish oil + EPO
- Registration Number
- NCT03516253
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- Histologically confirmed breast cancer,
- Clinical Stadium III and IV,
- Patients able to understand requirements of the study and provide written informed consent-
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Fish oil + EPO 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.
- Primary Outcome Measures
Name Time Method Change in quality of life 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.
Change in disease status Baseline, 3 months, 1 year Remission, stable disease or progression
- Secondary Outcome Measures
Name Time Method Changes in plasma fatty acids profiles Baseline, 3 months, 1 year Changes in plasma fatty acids profiles from baseline to endpoint
Changes in interleukins Baseline, 3 months, 1 year Changes in interleukins (IL)-6, 8,10 and TNF alpha from baseline to endpoint
Changes in activity of superoxide dismutase. Baseline, 3 months, 1 year Measures of activity of superoxide dismutase.
Changes in nutritional status Baseline, 3 months, 1 year Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Changes in activity of glutathion peroxidase. Baseline, 3 months, 1 year Measures of activity of glutathion peroxidase.
Changes in lipid profiles Baseline, 3 months, 1 year Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Changes in activity of catalase. Baseline, 3 months, 1 year Measures of activity of catalase.
Changes in activity of glutathion reductase. Baseline, 3 months, 1 year Measures of activity of glutathion reductase.
Trial Locations
- Locations (2)
Military medical academy
🇷🇸Belgrade, Serbia
University of Belgrade
🇷🇸Belgrade, Serbia