Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06214598

Run by

University of Belgrade

People needed

90

Starts

2024-03-01

Expected to finish

2026-11-30

Last updated by the study team

2024-05-09

Who can join

Age: 45 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Clinical Hospital Center Bezanijska kosa — Belgrade, Serbia (enrolling)
• Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade — Belgrade, Serbia (enrolling)

Full record on ClinicalTrials.gov

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