Recruiting
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
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.
ClinicalTrials.gov IDNCT06214598
PhaseNA
Enrollment90
SponsorUniversity of Belgrade
Age45 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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.
Interventions
- Dietary Supplement: Supplement — Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
- Dietary Supplement: AI diet — diet rich in whole grains, healthy oils and polyphenols,
- Dietary Supplement: Placebo — Placebo caps with standard diet
Primary outcomes
- Nutritional status (baseline, 4 months, 1 year)
- Nutritional status (baseline, 4 months, 1 year)
- Nutritional status (baseline, 4 months, 1 year)
- Changes in Quality of life (baseline, 4 months)
- Changes in Quality of life (baseline, 4 months)
- Changes in Quality of life (baseline, 4 months)
- Clinical outcome (baseline, 4 months, 1 year)
- Clinical outcome (baseline, 4 months, 1 year)
Eligibility information
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
Study locations
- Clinical Hospital Center Bezanijska kosa, Belgrade, 11070 Serbia
- Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, Belgrade, 11129 Serbia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.