Fish Oil and EPO in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516253
• Other study ID #: VMA-253-18
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: June 20, 2024

Study information

• Verified date: May 2022
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• Fish oil + EPO
Supplementation with both fish oil and EPO

Locations

Country	Name	City	State
Serbia	Military medical academy	Belgrade
Serbia	University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease status	Remission, stable disease or progression	Baseline, 3 months, 1 year
Primary	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	Changes in nutritional status	Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint	Baseline, 3 months, 1 year
Secondary	Changes in lipid profiles	Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint	Baseline, 3 months, 1 year
Secondary	Changes in plasma fatty acids profiles	Changes in plasma fatty acids profiles from baseline to endpoint	Baseline, 3 months, 1 year
Secondary	Changes in interleukins	Changes in interleukins (IL)-6, 8,10 and TNF alpha from baseline to endpoint	Baseline, 3 months, 1 year
Secondary	Changes in activity of superoxide dismutase.	Measures of activity of superoxide dismutase.	Baseline, 3 months, 1 year
Secondary	Changes in activity of catalase.	Measures of activity of catalase.	Baseline, 3 months, 1 year
Secondary	Changes in activity of glutathion peroxidase.	Measures of activity of glutathion peroxidase.	Baseline, 3 months, 1 year
Secondary	Changes in activity of glutathion reductase.	Measures of activity of glutathion reductase.	Baseline, 3 months, 1 year