Fish Oil and EPO in Breast Cancer

University of Belgrade

Status: Enrolling

Conditions: Breast Cancer

Treatments: Dietary Supplement: Fish oil + EPO

Study type: Interventional

Funder types: Other

Identifiers

NCT03516253

VMA-253-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Dietary Supplement: Fish oil + EPO

Control group

No Intervention group

Description:

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