Improving quality of life for breast cancer patients on aromatase inhibitors with an anti-inflammatory diet
Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
This study is testing if an anti-inflammatory diet or supplements can help breast cancer survivors on aromatase inhibitors feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Belgrade Academic / other |
| Locations | 2 sites (Belgrade and 1 other locations) |
| Trial ID | NCT06214598 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the quality of life and reduce side effects for breast cancer survivors undergoing aromatase inhibitor therapy through an anti-inflammatory diet or supplementation. The study involves a three-arm randomized controlled trial with 90 participants who will receive either a dietary intervention, a supplement, or a placebo over four months. Researchers will assess changes in nutritional status, quality of life, and various clinical parameters to establish the effectiveness of the dietary approach. The goal is to integrate nutritional interventions into the standard care for breast cancer patients to improve their overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45 to 70 with early-stage, hormone receptor-positive breast cancer who are currently on aromatase inhibitors.
Not a fit: Patients with metastatic disease, HER2-positive tumors, or significant chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and clinical outcomes for breast cancer patients undergoing aromatase inhibitor therapy.
How similar studies have performed: While nutritional interventions in cancer care are being explored, this specific approach combining diet with aromatase inhibitors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belgrade and 1 other locations
- Clinical Hospital Center Bezanijska kosa — Belgrade, Serbia (Recruiting)
- Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade — Belgrade, Serbia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.