Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Breast Cancer Clinical Trial

— AID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214598
• Other study ID #: AID5050
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• Supplement
Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
• AI diet
diet rich in whole grains, healthy oils and polyphenols,
• Placebo
Placebo caps with standard diet

Locations

Country	Name	City	State
Serbia	Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade	Belgrade
Serbia	Clinical Hospital Center Bezanijska kosa	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	assessed through blood cells count	baseline, 4 months, 1 year
Primary	Nutritional status	assessed through body mass index-BMI	baseline, 4 months, 1 year
Primary	Nutritional status	assessed through body composition- lean tissue, fat tissue and body water (in kg)	baseline, 4 months, 1 year
Primary	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
Primary	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
Primary	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
Primary	Clinical outcome	assessed through Laboratory analyses including BRC marker CA 15-3	baseline, 4 months, 1 year
Primary	Clinical outcome	assessed through potential complications and side-effects	baseline, 4 months, 1 year
Secondary	Inflammatory status	levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-a	baseline, 4 months,
Secondary	Redox status	total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L	baseline, 4 months,
Secondary	Redox status	superoxide dismutase (SOD)	baseline, 4 months,
Secondary	Redox status	thiobarbituric acid reactive substances (TBARS)	baseline, 4 months,
Secondary	leptin and adiponectin	plasma levels of leptin and adiponectin	baseline, 4 months
Secondary	Fatty acid status	Fatty acid mol% of plasma phospholipids	baseline, 4 months
Secondary	Lipidomic analysis	LC-MS lipids analysis	baseline, 4 months
Secondary	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