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Recruiting NCT06214598

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supplement, AI diet, Placebo.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 45 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

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

Primary outcome measures

  • Nutritional status [Time frame: baseline, 4 months, 1 year]
  • Nutritional status [Time frame: baseline, 4 months, 1 year]
  • Nutritional status [Time frame: baseline, 4 months, 1 year]
  • Changes in Quality of life [Time frame: baseline, 4 months]
  • Changes in Quality of life [Time frame: baseline, 4 months]
  • Changes in Quality of life [Time frame: baseline, 4 months]
  • Clinical outcome [Time frame: baseline, 4 months, 1 year]
  • Clinical outcome [Time frame: baseline, 4 months, 1 year]
Secondary outcome measures (8)
  • Inflammatory status [Time frame: baseline, 4 months,]
  • Redox status [Time frame: baseline, 4 months,]
  • Redox status [Time frame: baseline, 4 months,]
  • Redox status [Time frame: baseline, 4 months,]
  • leptin and adiponectin [Time frame: baseline, 4 months]
  • Fatty acid status [Time frame: baseline, 4 months]
  • Lipidomic analysis [Time frame: baseline, 4 months]
  • FADS1/FADS2 [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Serbia · 2 centers
  • Clinical Hospital Center Bezanijska kosa — Belgrade
  • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, — Belgrade

Identifiers

NCT: NCT06214598 · AID5050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗