Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

NCT06214598 | Recruiting

• 1 other identifier: AID5050
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (8)

• Nutritional status

  assessed through blood cells count

  baseline, 4 months, 1 year

• Nutritional status

  assessed through body mass index-BMI

  baseline, 4 months, 1 year

• Nutritional status

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

  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).

  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.

  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.

  baseline, 4 months

• Clinical outcome

  assessed through Laboratory analyses including BRC marker CA 15-3

  baseline, 4 months, 1 year

• Clinical outcome

  assessed through potential complications and side-effects

  baseline, 4 months, 1 year

Secondary Outcomes (8)

• Inflammatory status

  baseline, 4 months,

• Redox status

  baseline, 4 months,

• Redox status

  baseline, 4 months,

• Redox status

  baseline, 4 months,

• leptin and adiponectin

  baseline, 4 months

Study Arms (3)

AI Diet

EXPERIMENTAL

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)

Dietary Supplement: AI diet

Supplements

ACTIVE COMPARATOR

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

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Supplement DIETARY_SUPPLEMENT

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

Supplements

AI diet DIETARY_SUPPLEMENT

diet rich in whole grains, healthy oils and polyphenols,

AI Diet

Placebo DIETARY_SUPPLEMENT

Placebo caps with standard diet

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (2)

Clinical Hospital Center Bezanijska kosa

Belgrade, 11070, Serbia

RECRUITING

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

Belgrade, 11129, Serbia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo capusuls will be identical as supplement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 19, 2024
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)