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)

Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia

Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade

Belgrade, Serbia

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NCT06214598


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