Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors (AID)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: AI diet; Dietary supplement: Supplement; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11129
    • Recruiting
    • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
    • Contact: Vesna Vucic, PhD; Phone Number: +381113031997; Email: vesna.vucic.imr@gmail.com
    • Contact: Danijela Ristic Medic, MD PhD
    • Principal Investigator: Vesna Vucic, PhD
  • Belgrade, Serbia, 11070
    • Recruiting
    • Clinical Hospital Center Bezanijska Kosa
    • Contact: Nebojsa Ivanovic, Dr; Phone Number: 0603947871; Email: ivanovicnebojsadr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 information consent

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI Diet; Personalised diet rich in whole grains high in fibres, vegetables (particularly leafy greens and tomatoes), polyphenol-rich fruits (berries), and n-3 FAs foods (fatty fish, nuts, seeds and oils)	Dietary supplement: AI diet; diet rich in whole grains, healthy oils and polyphenols,
Active Comparator: Supplements; 2 gel capsules/d of fish oil (FO) + 3 gel capsules/d of evening primrose oil (EPO), containing 600 mg EPA, 400 mg DHA and 351 mg GLA + Standard diet: 55% carbohydrate, 15% protein and 30% fats	Dietary supplement: Supplement; Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
Placebo Comparator: Placebo; Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules	Dietary supplement: Placebo; Placebo caps with standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	assessed through blood cells count	baseline, 4 months, 1 year
Nutritional status	assessed through body mass index-BMI	baseline, 4 months, 1 year
Nutritional status	assessed through body composition- lean tissue, fat tissue and body water (in kg)	baseline, 4 months, 1 year
Clinical outcome	assessed through Laboratory analyses including BRC marker CA 15-3	baseline, 4 months, 1 year
Clinical outcome	assessed through potential complications and side-effects	baseline, 4 months, 1 year
Changes in Quality of life	assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).	baseline, 4 months
Changes in Quality of life	assessed through the questionnaires EORTC QLQ-C30. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much, except the two items of the global quality of life which use a modified 7-point linear analogue scale ranging from 1- very bad to 7- excellent.	baseline, 4 months
Changes in Quality of life	assessed through the questionnaires QLQ-BR23. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much.	baseline, 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory status	levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α	baseline, 4 months,
Redox status	total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L	baseline, 4 months,
Redox status	superoxide dismutase (SOD)	baseline, 4 months,
Redox status	thiobarbituric acid reactive substances (TBARS)	baseline, 4 months,
leptin and adiponectin	plasma levels of leptin and adiponectin	baseline, 4 months
Fatty acid status	Fatty acid mol% of plasma phospholipids	baseline, 4 months
Lipidomic analysis	LC-MS lipids analysis	baseline, 4 months
FADS1/FADS2	Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602	baseline

Collaborators and Investigators

• Sponsor: University of Belgrade

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AID5050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No