Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
Recruiting · NCT06214598 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Belgrade
View the official record on ClinicalTrials.gov →Interventions studied
AI dietPlaceboSupplement
What this trial is about
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.
Who can take part
Age range
45 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Clinical Hospital Center Bezanijska kosa - Belgrade, Serbia
- Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade - Belgrade, Serbia