Improving quality of life for breast cancer patients on aromatase inhibitors with an anti-inflammatory diet
Official title: Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
Run by University of Belgrade · NCT06214598 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 70 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | University of Belgrade Academic / other |
| Locations | 2 sites (Belgrade and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | March 31, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | May 9, 2024 |
| Trial ID | NCT06214598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with metastatic disease, HER2-positive tumors, or significant chronic illnesses may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.