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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
7,000
Patients from this group will receive selenium supplement to achieve optimal selenium level
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
Read-Gene S.A.
Grzepnica, West Pomeranian Voivodeship, Poland
Development of any new cancer
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.
Time frame: within 60 months of the study
Development of new breast cancer
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.
Time frame: within 60 months of the study
Proportion of any other cancers (besides breast cancers) at the end of 60 months
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.
Time frame: within 60 months of the study
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