Clinical trial NCT04014283: Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.
Official title: Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Selenium
Supplement
Prevention
Females
Risk
Lead sponsor: Read-Gene S.A.
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
name: IQ Pharma S.A.
name: West Pomeranian University of Technology
name: Vipharm S.A.
First posted: 2019-07-10
Enrollment: 7000
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Development of any new cancer
timeFrame: within 60 months of the study
Secondary outcomes:
measure: Development of new breast cancer
timeFrame: within 60 months of the study
measure: Proportion of any other cancers (besides breast cancers) at the end of 60 months
timeFrame: within 60 months of the study
Other outcomes:
Locations:
city: Grzepnica
country: Poland
facility: Read-Gene S.A.
state: West Pomerania
Study officials:
affiliation: Read-Gene S.A.
name: Jan Lubiński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Read-Gene S.A.
name: Cezary Cybulski, MD, PhD
role: STUDY_CHAIR
affiliation: Read-Gene S.A.
name: Jacek Gronwald, MD, PhD
role: STUDY_CHAIR
affiliation: Read-Gene S.A.
name: Tomasz Huzarski, MD, PhD
role: STUDY_CHAIR
name: Anna Jakubowska, MD, PhD
role: STUDY_CHAIR
name: Antoni Morawski, PhD
role: STUDY_CHAIR
affiliation: Read-Gene S.A.
name: Ewa Stachowska, PhD
role: STUDY_CHAIR
name: Edyta Balejko, PhD
role: STUDY_CHAIR
name: Karolina Ertmańska, PhD
role: STUDY_CHAIR
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