NCT06214598

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Belgrade · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supplement	Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
DIETARY_SUPPLEMENT	AI diet	diet rich in whole grains, healthy oils and polyphenols,
DIETARY_SUPPLEMENT	Placebo	Placebo caps with standard diet

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-31
• Completion: 2026-11-30
• First posted: 2024-01-19
• Last updated: 2024-05-09

Locations

2 sites across 1 country: Serbia