Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

University of Belgrade90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer

Interventions

SupplementDIETARY_SUPPLEMENT

Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid

AI dietDIETARY_SUPPLEMENT

diet rich in whole grains, healthy oils and polyphenols,

PlaceboDIETARY_SUPPLEMENT

Placebo caps with standard diet

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia

RECRUITING

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

Belgrade, Serbia

RECRUITING

Outcomes

Primary Outcomes

Nutritional status

assessed through blood cells count

Time frame: baseline, 4 months, 1 year

Nutritional status

assessed through body mass index-BMI

Time frame: baseline, 4 months, 1 year

Nutritional status

assessed through body composition- lean tissue, fat tissue and body water (in kg)

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: baseline, 4 months

Clinical outcome

assessed through Laboratory analyses including BRC marker CA 15-3

Time frame: baseline, 4 months, 1 year

Clinical outcome

assessed through potential complications and side-effects

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Inflammatory status

levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α

Time frame: baseline, 4 months,

Redox status

total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L

Time frame: baseline, 4 months,

Redox status

superoxide dismutase (SOD)

Time frame: baseline, 4 months,

Redox status

thiobarbituric acid reactive substances (TBARS)

Time frame: baseline, 4 months,

leptin and adiponectin

plasma levels of leptin and adiponectin

Time frame: baseline, 4 months

Fatty acid status

Fatty acid mol% of plasma phospholipids

Time frame: baseline, 4 months

Lipidomic analysis

LC-MS lipids analysis

Time frame: 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

Time frame: baseline