Clinical trial NCT06214598: Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
Official title: Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AID project consists of a 3-arm clinical trial in BRC patients with 4-month nutritional intervention to assess the effects of personalized anti-inflammatory diet enriched with anti-inflammatory PUFA, or PUFA supplemental pills in 90 postmenopausal BRC patients receiving AI, randomly assigned in a ratio of 1:1:1 (diet:supplements:placebo). Since inflammation and oxidative stress are important promoters of cancer development and progression, we have chosen Fish oil and evening primrose oil as the richest sources of anti-inflammatory PUFA (n-3 and n-6). Anti-inflammatory diet enriched with PUFA and polyphenols was beneficial n many chronic diseases, and is named fatigue-reduction diet, especially relevant here as the fatigue is one of the most common side effects of AI. We will test the hypothesis that these interventions improve patients' nutritional status, QoL and clinical outcomes, by decreasing systemic inflammation and oxidative stress and reverting disrupted lipid metabolism.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nutritional status
timeFrame: baseline, 4 months, 1 year
measure: Nutritional status
timeFrame: baseline, 4 months, 1 year
measure: Nutritional status
timeFrame: baseline, 4 months, 1 year
measure: Changes in Quality of life
timeFrame: baseline, 4 months
measure: Changes in Quality of life
timeFrame: baseline, 4 months
measure: Changes in Quality of life
timeFrame: baseline, 4 months
measure: Clinical outcome
timeFrame: baseline, 4 months, 1 year
measure: Clinical outcome
timeFrame: baseline, 4 months, 1 year
Secondary outcomes:
measure: Inflammatory status
timeFrame: baseline, 4 months,
measure: Redox status
timeFrame: baseline, 4 months,
measure: Redox status
timeFrame: baseline, 4 months,
measure: Redox status
timeFrame: baseline, 4 months,
measure: leptin and adiponectin
timeFrame: baseline, 4 months
measure: Fatty acid status
timeFrame: baseline, 4 months
measure: Lipidomic analysis
timeFrame: baseline, 4 months
measure: FADS1/FADS2
timeFrame: baseline
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska kosa
city: Belgrade
country: Serbia
facility: Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Study officials:
References: