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Spots Global Cancer Trial Database for Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

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Trial Identification

Brief Title: Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

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

Study ID: NCT06214598

Conditions

Breast Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Clinical Hospital Center Bezanijska kosa, Belgrade, , Serbia

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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