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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
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| Placebo | Placebo Comparator | Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement | Dietary Supplement | Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory status | levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α | baseline, 4 months, |
| Redox status | total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Center Bezanijska kosa | Recruiting | Belgrade | 11070 | Serbia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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Placebo capusuls will be identical as supplement
| AI diet | Dietary Supplement | diet rich in whole grains, healthy oils and polyphenols, |
|
| Placebo | Dietary Supplement | Placebo caps with standard diet |
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| Clinical outcome | assessed through potential complications and side-effects | baseline, 4 months, 1 year |
| baseline, 4 months, |
| Redox status | superoxide dismutase (SOD) | baseline, 4 months, |
| Redox status | thiobarbituric acid reactive substances (TBARS) | baseline, 4 months, |
| leptin and adiponectin | plasma levels of leptin and adiponectin | baseline, 4 months |
| Fatty acid status | Fatty acid mol% of plasma phospholipids | baseline, 4 months |
| Lipidomic analysis | LC-MS lipids analysis | baseline, 4 months |
| FADS1/FADS2 | Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602 | baseline |
| Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade | Recruiting | Belgrade | 11129 | Serbia |
|
| D017437 |
| Skin and Connective Tissue Diseases |