Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Last updated: May 7, 2024
Sponsor: University of Belgrade
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

AI diet

Supplement

Placebo

Clinical Study ID

NCT06214598
AID5050
  • Ages 45-70
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 informationconsent

Exclusion

Exclusion Criteria:

  • 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 nutsfruits.
  • 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 monthsbefore the start of the study

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: AI diet
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
November 30, 2026

Study 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 side effects. Nutritional intervention can ameliorate undesirable effects, reduce exhaustion, psychological harm, and costs spent on treating these side effects. The proposed project AID aims to improve clinical outcome, quality of life (QoL) and survival rate in BRC patients on adjuvant endocrine therapy with aromatase inhibitors (AI) by nutritional interventions. In a three-arm randomised controlled nutritional trial involving 90 BRC patients who will receive either supplement or placebo pills (control group), or an anti-inflammatory diet for 4 months, along with the AI therapy, changes in nutritional status, QoL, biochemical and clinical parameters will be measured in comparison among three groups. The second goal is to establish cause-and-effect relationships among the clinical outcomes, nutritional status and biochemical parameters related to cancer, including inflammatory and redox status, plasma lipidome and polymorphism of fatty acid desaturase (FADS) genes. Introducing an effective nutritional intervention in BRC patients as an integral part of the multimodal therapeutic approach is the goal of this project.

Connect with a study center

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

    Belgrade, 11129
    Serbia

    Active - Recruiting

  • Clinical Hospital Center Bezanijska kosa

    Belgrade, 11070
    Serbia

    Active - Recruiting

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