Title
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.
Phase
N/ALead Sponsor
Read-Gene S.A.Study Type
InterventionalStatus
Active, not recruitingIndication/Condition
Breast NeoplasmsIntervention/Treatment
Selenium supplementation or placebo treatment Selenium supplementation or placebo treatment and diet modification ...Study Participants
7000Hypothesis 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.
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
Placebo: 100 Supplement: 100
Diet modification: 500 Observation: 500
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
Diet modification: 1100 Observation: 1100
Diet modification: 200 Observation: 200
Inclusion Criteria: - Sub-group I - BRCA1 mutation carriers Carrier-status of BRCA1 mutation Age >20 years Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment Be able to give information consent and sign an informed consent form Be willing to comply with all of the study procedures as per the protocol Be willing to inform researchers about current or any new pregnancy Sub-optimal Se level in the blood Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations Age ≥40 years Age ≥20 years for women that have been diagnosed previously with breast cancer Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1) No personal history of cancer except for breast cancer and non-melanoma skin cancers Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment Be able to give information consent and sign an informed consent form Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA) Be willing to comply with all of the study procedures as per the protocol Be willing to inform researchers about current or any new pregnancy Sub-optimal Se level in the blood Exclusion Criteria: Sub-group I - BRCA1 mutation carriers Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment Current pregnancy or breast-feeding Optimal Se level in the blood Age <20 years Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only) Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1) Presence of BRCA1 mutation Current pregnancy or breast-feeding Optimal Se level in the blood Age <40 years except for women that have been previously diagnosed with breast cancer Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only)
