NCT06214598 Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
| NCT ID | NCT06214598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Belgrade |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-03-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.
Eligibility Criteria
Inclusion Criteria: * Age: 45 to 70 years * Postmenopausal women * Histologically confirmed BRC, stage I to IIIa * ER positive /HER2 negative * Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months * Body mass index from 20 to 34.9 kg/m 2 * Able to understand the requirements of the study and provide written information consent Exclusion Criteria: * Metastatic or locally advanced disease * HER2-positive tumors * Presence of other malignant or serious chronic diseases * Active infections * Previous stroke or heart attack, * Rheumatoid arthritis and other types of autoimmune diseases * Presence of a significant neurological deficit * Dementia * Allergy to the ingredients of the dietary preparation or to fish, fish oil and nuts fruits. * Allergies to evening primrose oil or other oils containing gamma-linolenic acid (borage, black currant) * Use of lipid-lowering drugs (statins, Normolip) * Current use of warfarin or other anticoagulants * Corticosteroid therapy for the last month * Use of dietary supplements based on fish oil, evening primrose, and flaxseed oils, omega 3-6-9 fatty acids, multivitamins with added omega-3 of fatty acids 3 months before the start of the study
Frequently Asked Questions
Who can join the NCT06214598 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06214598 currently recruiting?
Yes, NCT06214598 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Belgrade to inquire about joining.
Where is the NCT06214598 trial being conducted?
This trial is being conducted at Belgrade, Serbia, Belgrade, Serbia.
Who is sponsoring the NCT06214598 clinical trial?
NCT06214598 is sponsored by University of Belgrade. The trial plans to enroll 90 participants.
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