Clinical trial NCT03516253: Fish Oil and EPO in Breast Cancer
Official title: Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in disease status
timeFrame: Baseline, 3 months, 1 year
measure: Change in quality of life
timeFrame: Baseline, 3 months, 1 year
Secondary outcomes:
measure: Changes in nutritional status
timeFrame: Baseline, 3 months, 1 year
measure: Changes in lipid profiles
timeFrame: Baseline, 3 months, 1 year
measure: Changes in plasma fatty acids profiles
timeFrame: Baseline, 3 months, 1 year
measure: Changes in interleukins
timeFrame: Baseline, 3 months, 1 year
measure: Changes in activity of superoxide dismutase.
timeFrame: Baseline, 3 months, 1 year
measure: Changes in activity of catalase.
timeFrame: Baseline, 3 months, 1 year
measure: Changes in activity of glutathion peroxidase.
timeFrame: Baseline, 3 months, 1 year
measure: Changes in activity of glutathion reductase.
timeFrame: Baseline, 3 months, 1 year
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Military medical academy
city: Belgrade
country: Serbia
facility: University of Belgrade
Study officials:
References: