Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors (AID)

University of Belgrade

Status: Enrolling

Conditions: Breast Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AI diet; Dietary Supplement: Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06214598

AID5050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

AI Diet

Experimental group

Description:

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)

Treatment:

Dietary Supplement: AI diet

Supplements

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Supplement

Placebo

Placebo Comparator group

Description:

Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules

Treatment:

Dietary Supplement: Placebo