Fish Oil and EPO in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03516253|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: Fish oil + EPO||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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 olive 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 olive oil.
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind|
|Primary Purpose:||Basic Science|
|Official Title:||Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer|
|Actual Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||April 20, 2020|
|Estimated Study Completion Date :||June 20, 2021|
Experimental: Intervention group
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
Supplementation with both fish oil and EPO
No Intervention: Control group
Dietary Supplement: Olive oil (5 gel capsules, each 1g olive oil), 3 months with lunch.
- Change in disease status [ Time Frame: Baseline, 3 months, 1 year ]Remission, stable disease or progression
- Change in quality of life [ Time Frame: 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.
- Changes in nutritional status [ Time Frame: Baseline, 3 months, 1 year ]Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
- Changes in lipid profiles [ Time Frame: Baseline, 3 months, 1 year ]Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
- Changes in plasma fatty acids profiles [ Time Frame: Baseline, 3 months, 1 year ]Changes in plasma fatty acids profiles from baseline to endpoint
- Changes in interleukins [ Time Frame: Baseline, 3 months, 1 year ]Changes in interleukins (IL)-1, 4, 6 and 10 from baseline to endpoint
- Changes in activity of superoxide dismutase. [ Time Frame: Baseline, 3 months, 1 year ]Measures of activity of superoxide dismutase.
- Changes in activity of catalase. [ Time Frame: Baseline, 3 months, 1 year ]Measures of activity of catalase.
- Changes in activity of glutathion peroxidase. [ Time Frame: Baseline, 3 months, 1 year ]Measures of activity of glutathion peroxidase.
- Changes in activity of glutathion reductase. [ Time Frame: Baseline, 3 months, 1 year ]Measures of activity of glutathion reductase.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516253
|Military medical academy||Recruiting|
|Belgrade, Serbia, 11000|
|Contact: Predrag Krstic, MD 653618461 ext +381 firstname.lastname@example.org|
|Contact: Aleksandra Arsic, PhD 605888553 ext +381 email@example.com|
|University of Belgrade||Not yet recruiting|
|Belgrade, Serbia, 11129|
|Contact: Aleksandra Arsic, PhD firstname.lastname@example.org|
|Contact: Vesna Vucic, PhD email@example.com|