Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Not Applicable

Recruiting

Interventions: Dietary Supplement: Supplement
Dietary Supplement: AI diet
Dietary Supplement: Placebo

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Supplements	Supplement	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
AI Diet	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)
Placebo	Placebo	Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules

Primary Outcome Measures

Name	Time	Method
Nutritional status	baseline, 4 months, 1 year	assessed through body composition- lean tissue, fat tissue and body water (in kg)
Changes in Quality of life	baseline, 4 months	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.
Clinical outcome	baseline, 4 months, 1 year	assessed through potential complications and side-effects

Secondary Outcome Measures

Name	Time	Method
leptin and adiponectin	baseline, 4 months	plasma levels of leptin and adiponectin
Lipidomic analysis	baseline, 4 months	LC-MS lipids analysis
Fatty acid status	baseline, 4 months	Fatty acid mol% of plasma phospholipids
Inflammatory status	baseline, 4 months,	levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α
FADS1/FADS2	baseline	Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602
Redox status	baseline, 4 months,	thiobarbituric acid reactive substances (TBARS)

Locations (2): Clinical Hospital Center Bezanijska kosa
🇷🇸
Belgrade, Serbia
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
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Belgrade, Serbia