An interventional study of Supplement and AI diet in Breast Cancer, sponsored by University of Belgrade. Recruiting at 2 sites in Serbia. Open to female participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Belgrade · Not applicable, Interventional, and Treatment
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 90 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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)
Dietary Supplement: AI diet
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
Dietary Supplement: Supplement
Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules
Dietary Supplement: Placebo
Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
diet rich in whole grains, healthy oils and polyphenols,
Placebo caps with standard diet
Nutritional status
assessed through blood cells count
Time frame: baseline, 4 months, 1 year
Nutritional status
assessed through body mass index-BMI
Time frame: baseline, 4 months, 1 year
Nutritional status
assessed through body composition- lean tissue, fat tissue and body water (in kg)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: baseline, 4 months
Clinical outcome
assessed through Laboratory analyses including BRC marker CA 15-3
Time frame: baseline, 4 months, 1 year
Clinical outcome
assessed through potential complications and side-effects
Time frame: baseline, 4 months, 1 year
Inflammatory status
levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α
Time frame: baseline, 4 months,
Redox status
total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L
Time frame: baseline, 4 months,
Redox status
superoxide dismutase (SOD)
Time frame: baseline, 4 months,
Redox status
thiobarbituric acid reactive substances (TBARS)
Time frame: baseline, 4 months,
leptin and adiponectin
plasma levels of leptin and adiponectin
Time frame: baseline, 4 months
Fatty acid status
Fatty acid mol% of plasma phospholipids
Time frame: baseline, 4 months
Lipidomic analysis
LC-MS lipids analysis
Time frame: 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
Time frame: baseline
Plan to share: No
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University of Belgrade