Breast Neoplasms
Conditions
Keywords
Selenium, Supplement, Prevention, Females, Risk
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSelenium supplementation or placebo treatment
Patients from this group will receive selenium supplement to achieve optimal selenium level
OTHERDiet modification
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
OTHERSelenium supplementation or placebo treatment and diet modification
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
Sponsors
National Center for Research and Development, Poland
IQ Pharma S.A.
West Pomeranian University of Technology
Vipharm S.A.
Read-Gene S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Sub-group I - BRCA1 mutation carriers 1. Carrier-status of BRCA1 mutation 2. Age \>20 years 3. Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment 4. Be able to give information consent and sign an informed consent form 5. Be willing to comply with all of the study procedures as per the protocol 6. Be willing to inform researchers about current or any new pregnancy 7. Sub-optimal Se level in the blood Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations 1. Age ≥40 years 2. Age ≥20 years for women that have been diagnosed previously with breast cancer 3. Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1) 4. No personal history of cancer except for breast cancer and non-melanoma skin cancers 5. Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment 6. Be able to give information consent and sign an informed consent form 7. Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA) 8. Be willing to comply with all of the study procedures as per the protocol 9. Be willing to inform researchers about current or any new pregnancy 10. Sub-optimal Se level in the blood
Exclusion criteria
Sub-group I - BRCA1 mutation carriers 1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers 2. Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment 3. Current pregnancy or breast-feeding 4. Optimal Se level in the blood 5. Age \<20 years 6. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 7. 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 1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers 2. Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment 3. Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1) 4. Presence of BRCA1 mutation 5. Current pregnancy or breast-feeding 6. Optimal Se level in the blood 7. Age \<40 years except for women that have been previously diagnosed with breast cancer 8. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 9. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of any new cancer | within 60 months of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of new breast cancer | within 60 months of the study | 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. |
| Proportion of any other cancers (besides breast cancers) at the end of 60 months | within 60 months of the study | 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. |
Countries
Poland
Outcome results
None listed