Status:
RECRUITING
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
Lead Sponsor:
University of Belgrade
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-70 years
Phase:
NA
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.
Detailed Description
With 2.1 million new breast cancer (BRC) cases each year globally, BRC is one of the biggest health challenges today. Available anticancer therapies have limited efficacy and are coupled with toxic si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06214598
Start Date
March 1 2024
End Date
November 30 2026
Last Update
May 9 2024
Active Locations (2)
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1
Clinical Hospital Center Bezanijska kosa
Belgrade, Serbia, 11070
2
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, Serbia, 11129