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This study examines the effect of an anti-inflammatory diet and a dietary supplement compared with placebo in breast cancer patients receiving aromatase inhibitor therapy. Postmenopausal women aged 45-70 with early-stage breast cancer may take part. The study is being conducted as a non-phase study and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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