Clinical trial for Breast Cancer
Official title Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
ClinicalTrials.gov ID: NCT06214598
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70, women only
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Belgrade, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belgrade, Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.