Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Antirheumatic Agents

Analgesics

Dermatologic Agents

Lipid Regulating Agents

Other Dietary Supplements

Herbal and Botanical

Aromatase Inhibitors

Evening primrose oil

Omega 3 Fatty Acid

Tomato

Evening Primrose

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)

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

Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules

Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid

Supplement

diet rich in whole grains, healthy oils and polyphenols,

AI diet

Placebo

Nebojsa Ivanovic, Dr

Vesna Vucic, PhD

Danijela Ristic Medic, MD PhD

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.

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.

Placebo capusuls will be identical as supplement

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors

assessed through body composition- lean tissue, fat tissue and body water (in kg)

assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).

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.

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.

assessed through Laboratory analyses including BRC marker CA 15-3

assessed through potential complications and side-effects

levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α

total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L

thiobarbituric acid reactive substances (TBARS)

Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602

University of Belgrade

Principal Investigator

Micronutrients

Mineral

Selenium

Antioxidants

Protective Agents

Trace Elements

Selenium Supplement

Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900

Diet modification: 1100 Observation: 1100

Patients from this group will receive selenium supplement to achieve optimal selenium level

Selenium supplementation or placebo treatment

Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.

Diet modification

In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood

Selenium supplementation or placebo treatment and diet modification

Jan Lubiński, MD, PhD

Cezary Cybulski, MD, PhD

Jacek Gronwald, MD, PhD

Tomasz Huzarski, MD, PhD

Anna Jakubowska, MD, PhD

Antoni Morawski, PhD

Ewa Stachowska, PhD

Edyta Balejko, PhD

Karolina Ertmańska, PhD

Hypothesis to be tested:

Oral supplementation or diet modifications of selenium to a specified range will be effective in reducing the risk of developing cancer of any type in women with high risk of breast cancer, as compared to placebo.

Primary Objective

• To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of any cancers in an at risk population of women over the 60 months of the study.

Secondary Objectives

* To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of breast cancer in an at risk population of women over the 60 months of the study.
* To explore the relationship between the effects of study supplement or diet modifications on cancer risk and genetic factors.

The study will have 7000 participants. All the measurements will be performed via blood tests.

Supplementation of selenium or diet modification will be effective in reducing the risk of developing breast cancer in women with high risk, as compared to placebo.

The null hypothesis assumes no significant differences between the supplementation and placebo groups. The alternative hypothesis assumes that patients with high risk of breast cancer in supplementation or diet modification group with optimal selenium level will have significantly reduced risk of developing cancer in relation to the placebo group with selenium deficiency. The comparison of disease-free survival time intervals is best covered by Cox Regression and is represented by a Kaplan-Meier survival curve tested by log- rank test.

The comparison of proportions of diseased and healthy subjects in the supplementation arm with respect to the placebo arm is best attempted using the Fisher Exact Test. Graphical representation should be based on bar plots for percentages and/or raw numbers, or a similar representation.

The selected randomization method is block randomization with randomly chosen blocks sizes.

Randomization must take place before 120 days after the Screening Visit (Day 0). After confirmation that the patient meets all eligibility criteria for the study, the patient will be randomly assigned (1:1) to either placebo or supplementation group. Patients with selenium deficiency can choose between diet modification and supplementation group.

The last step of randomisation is the blinding/assigning procedure - connecting randomization numbers with placebo or supplement packages numbers and assigning them to the subjects. All SELINA personnel, participants and clinicians will be blinded to the treatment allocation; only the Statistical Center will have the possibility to unblind the data.

Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.

Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.

We still did not collect all the required participants. It is hard to tell that the data could be useful later on.

Cancer diagnosis will be determined by routine clinical management and confirmed by central pathology review. Cancer-free survival is defined as the period of time between randomization and diagnosis of cancer, or - for patients who do not develop cancer - the period of time between randomization and last contact or death unrelated to cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors	NCT06214598	Breast Cancer	Supplement AI diet Placebo	45 Years - 70 Years	University of Belgrade
Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.	NCT04014283	Breast Neoplasm...	Selenium supple... Diet modificati... Selenium supple...	21 Years -	Read-Gene S.A.

Spots Global Cancer Trial Database for supplement

Every month we try and update this database with for supplement cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for supplement

Every month we try and update this database with for supplement cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for supplement cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.