Breast Cancer
Conditions
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTSupplement
Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
DIETARY_SUPPLEMENTAI diet
diet rich in whole grains, healthy oils and polyphenols,
DIETARY_SUPPLEMENTPlacebo
Placebo caps with standard diet
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Placebo capusuls will be identical as supplement
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | baseline, 4 months, 1 year | assessed through blood cells count |
| Changes in Quality of life | baseline, 4 months | assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much). |
| Clinical outcome | baseline, 4 months, 1 year | assessed through Laboratory analyses including BRC marker CA 15-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatty acid status | baseline, 4 months | Fatty acid mol% of plasma phospholipids |
| Inflammatory status | baseline, 4 months, | levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α |
| FADS1/FADS2 | baseline | Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602 |
| Lipidomic analysis | baseline, 4 months | LC-MS lipids analysis |
| Redox status | baseline, 4 months, | total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L |
| leptin and adiponectin | baseline, 4 months | plasma levels of leptin and adiponectin |
Countries
Serbia
Outcome results
None listed