Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.
NCT ID: NCT04014283
Last Updated: 2023-04-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
7000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-10-31
Study Completion Date
2023-11-30
Brief Summary
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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.
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.
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Detailed Description
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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.
• 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.
Conditions
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Breast Neoplasms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 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.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Investigators
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.
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.
Study Groups
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BRCA(+) Selenium deficiency
Placebo: 100 Supplement: 100
Group Type
ACTIVE_COMPARATOR
Selenium supplementation or placebo treatment
Intervention Type
DIETARY_SUPPLEMENT
Patients from this group will receive selenium supplement to achieve optimal selenium level
BRCA(+) Selenium excess
Diet modification: 500 Observation: 500
Group Type
ACTIVE_COMPARATOR
Diet modification
Intervention Type
OTHER
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
BRCA(-) Selenium deficiency
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
Group Type
ACTIVE_COMPARATOR
Selenium supplementation or placebo treatment and diet modification
Intervention Type
OTHER
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
BRCA(-) Selenium excess
Diet modification: 1100 Observation: 1100
Group Type
ACTIVE_COMPARATOR
Diet modification
Intervention Type
OTHER
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
BRCA(+) Selenium excess, age > 50
Diet modification: 200 Observation: 200
Group Type
ACTIVE_COMPARATOR
Diet modification
Intervention Type
OTHER
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
Interventions
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Selenium supplementation or placebo treatment
Patients from this group will receive selenium supplement to achieve optimal selenium level
Intervention Type
DIETARY_SUPPLEMENT
Diet 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.
Intervention Type
OTHER
Selenium 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
Intervention Type
OTHER
Eligibility Criteria
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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
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)
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)
Minimum Eligible Age
21 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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National Center for Research and Development, Poland
OTHER
Sponsor Role
collaborator
IQ Pharma S.A.
UNKNOWN
Sponsor Role
collaborator
West Pomeranian University of Technology
UNKNOWN
Sponsor Role
collaborator
Vipharm S.A.
UNKNOWN
Sponsor Role
collaborator
Read-Gene S.A.
OTHER
Sponsor Role
lead
Responsible Party
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Lubinski Jan
MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jan Lubiński, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Read-Gene S.A.
Cezary Cybulski, MD, PhD
Role: STUDY_CHAIR
Read-Gene S.A.
Jacek Gronwald, MD, PhD
Role: STUDY_CHAIR
Read-Gene S.A.
Tomasz Huzarski, MD, PhD
Role: STUDY_CHAIR
Read-Gene S.A.
Anna Jakubowska, MD, PhD
Role: STUDY_CHAIR
Antoni Morawski, PhD
Role: STUDY_CHAIR
Ewa Stachowska, PhD
Role: STUDY_CHAIR
Read-Gene S.A.
Edyta Balejko, PhD
Role: STUDY_CHAIR
Karolina Ertmańska, PhD
Role: STUDY_CHAIR
Locations
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Read-Gene S.A.
Grzepnica, West Pomeranian Voivodeship, Poland
Site Status
Countries
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Poland
References
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Related Links
Access external resources that provide additional context or updates about the study.
https://www.nice.org.uk/guidance/cg164/evidence
Clinical Guidelines for the classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care, NICE, 2013, National Collaborating Centre for Cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INNOMED/I/16?NCBR/2014
Identifier Type: -
Identifier Source: org_study_id
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