Prevention of Female Cancers by Optimization of Selenium Levels in the Organism. (SELINA)

Read-Gene S.A.

Status: Active, not recruiting

Conditions: Breast Neoplasms

Treatments: Dietary Supplement: Selenium supplementation or placebo treatment; Other: Selenium supplementation or placebo treatment and diet modification; Other: Diet modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04014283

INNOMED/I/16?NCBR/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,000 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7,000 participants in 5 patient groups

BRCA(+) Selenium deficiency

Active Comparator group

Description:

Placebo: 100 Supplement: 100

Treatment:

Dietary Supplement: Selenium supplementation or placebo treatment

BRCA(+) Selenium excess

Active Comparator group

Description:

Diet modification: 500 Observation: 500

Treatment:

Other: Diet modification

BRCA(-) Selenium deficiency

Active Comparator group

Description:

Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900

Treatment:

Other: Selenium supplementation or placebo treatment and diet modification

BRCA(-) Selenium excess

Active Comparator group

Description:

Diet modification: 1100 Observation: 1100

Treatment:

Other: Diet modification

BRCA(+) Selenium excess, age > 50

Active Comparator group

Description:

Diet modification: 200 Observation: 200

Treatment:

Other: Diet modification