Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-02-20
2024-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention
NCT01282580
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
NCT00627276
Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
NCT00114296
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
NCT02352779
Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women
NCT02816125
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Fish oil + EPO
Supplementation with both fish oil and EPO
Control group
Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fish oil + EPO
Supplementation with both fish oil and EPO
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical Stadium III and IV,
* Patients able to understand requirements of the study and provide written informed consent-
Exclusion Criteria
* 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
45 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Belgrade
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aleksandra Arsic
Research Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Military medical academy
Belgrade, , Serbia
University of Belgrade
Belgrade, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Arsic A, Krstic P, Paunovic M, Nedovic J, Jakovljevic V, Vucic V. Anti-inflammatory effect of combining fish oil and evening primrose oil supplementation on breast cancer patients undergoing chemotherapy: a randomized placebo-controlled trial. Sci Rep. 2023 Apr 20;13(1):6449. doi: 10.1038/s41598-023-28411-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VMA-253-18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.