RecruitingNot ApplicableNCT06214598
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
Sponsor
University of Belgrade
Enrollment
90 participants
Start Date
Mar 1, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 45 YearsMax Age: 70 Years
Inclusion Criteria7
- 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 Criteria14
- 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
Interventions
DIETARY_SUPPLEMENTSupplement
Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
DIETARY_SUPPLEMENTAI diet
diet rich in whole grains, healthy oils and polyphenols,
DIETARY_SUPPLEMENTPlacebo
Placebo caps with standard diet
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06214598
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