Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

All Drugs and Chemicals

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.

Spots Global Cancer Trial Database for Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.

Trial Identification

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Study Description

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