Actively Recruiting

Phase Not Applicable
Age: 45Years - 70Years
FEMALE
NCT06214598

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Led by University of Belgrade · Updated on 2024-05-09

90

Participants Needed

2

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Who Can Participate

Age: 45Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age: 45 to 70 years
  • Postmenopausal women
  • Histologically confirmed breast cancer, stage I to IIIa
  • Estrogen receptor positive / HER2 negative
  • Receiving adjuvant hormone therapy with aromatase inhibitors for 6 to 30 months
  • Body mass index from 20 to 34.9 kg/m2
  • Able to understand study requirements and provide written informed consent
Not Eligible

You will not qualify if you...

  • Metastatic or locally advanced disease
  • HER2-positive tumors
  • Other malignant or serious chronic diseases
  • Active infections
  • Previous stroke or heart attack
  • Rheumatoid arthritis or other autoimmune diseases
  • Significant neurological deficits
  • Dementia
  • Allergy to study dietary ingredients, fish, fish oil, nuts, or fruits
  • Allergy to evening primrose oil or oils with gamma-linolenic acid
  • Use of lipid-lowering drugs (statins, Normolip)
  • Current use of warfarin or other anticoagulants
  • Corticosteroid therapy within the last month
  • Use of dietary supplements containing fish oil, evening primrose, flaxseed oils, omega 3-6-9 fatty acids, or multivitamins with omega-3 within 3 months before study start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia, 11070

Actively Recruiting

2

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

Belgrade, Serbia, 11129

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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