Breast CancerNCT03516253
Fish Oil and EPO in Breast Cancer
A study testing Fish oil + EPO in people with Breast Cancer, run by University of Belgrade at 2 sites in Serbia.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fish oil + EPO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSerbia
- Study dates
- 20 Feb 2019to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer,
- Clinical Stadium III and IV,
- Patients able to understand requirements of the study and provide written informed consent-
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Serbia2 sites, 2 recruiting
- Recruiting
Military medical academy
Belgrade, 11000
Predrag Krstic, MD, 653618461 ext. +381, vesna.vucic.imr@gmail.com
Aleksandra Arsic, PhD, 605888553 ext. +381, aleksandraarsicimi@gmail.com
- Not yet recruiting
University of Belgrade
Belgrade, 11129
Aleksandra Arsic, PhD, aleksandraarsicimi@gmail.com
Vesna Vucic, PhD, vesna.vucic.imr@gmail.com
About this study
Official title: Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Fish oil + EPO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil + EPODietary supplement
Supplementation with both fish oil and EPO
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Dietary Supplement: Fish oil + EPO |
| Control group | No intervention | Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease status
Remission, stable disease or progression
Measured: Baseline, 3 months, 1 year
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.
Measured: Baseline, 3 months, 1 year
Secondary outcomes (8)
Changes in nutritional status
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Measured: Baseline, 3 months, 1 year
Changes in lipid profiles
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Measured: Baseline, 3 months, 1 year
Changes in plasma fatty acids profiles
Changes in plasma fatty acids profiles from baseline to endpoint
Measured: Baseline, 3 months, 1 year
Changes in interleukins
Changes in interleukins (IL)-6, 8,10 and TNF alpha from baseline to endpoint
Measured: Baseline, 3 months, 1 year
Changes in activity of superoxide dismutase.
Measures of activity of superoxide dismutase.
Measured: Baseline, 3 months, 1 year
Changes in activity of catalase.
Measures of activity of catalase.
Measured: Baseline, 3 months, 1 year
Changes in activity of glutathion peroxidase.
Measures of activity of glutathion peroxidase.
Measured: Baseline, 3 months, 1 year
Changes in activity of glutathion reductase.
Measures of activity of glutathion reductase.
Measured: Baseline, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start20 Feb 2019
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Arsic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516253
- Sponsor's protocol ID
- VMA-253-18
- Status last verified
- May 2022
- First submitted
- 6 Mar 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37081029
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT03516253
- Acronym / sponsor ID
- VMA-253-18
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Fish oil + EPODietary 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. |
| Control group | No intervention | –Dietary Supplement: Mineral oil (5 gel capsules, each 1g mineral oil), 3 months with lunch. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed breast cancer,
- Clinical Stadium III and IV,
- Patients able to understand requirements of the study and provide written informed consent-
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil + EPOSupplementation with both fish oil and EPO | Dietary supplement | Intervention group |
Primary outcome
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.
8 secondary outcomes
Changes in nutritional status
Time frame: Baseline, 3 months, 1 year
Changes in lipid profiles
Time frame: Baseline, 3 months, 1 year
Changes in plasma fatty acids profiles
Time frame: Baseline, 3 months, 1 year
Changes in interleukins
Time frame: Baseline, 3 months, 1 year
Changes in activity of superoxide dismutase.
Time frame: Baseline, 3 months, 1 year
Changes in activity of catalase.
Time frame: Baseline, 3 months, 1 year
Changes in activity of glutathion peroxidase.
Time frame: Baseline, 3 months, 1 year
Changes in activity of glutathion reductase.
Time frame: Baseline, 3 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 37081029Arsic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil + EPO in people with Breast Cancer, run by University of Belgrade at 2 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease status (time frame: Baseline, 3 months, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.