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

Breast Neoplasms Clinical Trial

— SELINA  

Official title:

Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04014283
• Other study ID #: INNOMED/I/16?NCBR/2014
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Read-Gene S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7000
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Dietary Supplement:
• Selenium supplementation or placebo treatment
Patients from this group will receive selenium supplement to achieve optimal selenium level

Other:
• 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.
• 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

Locations

Country	Name	City	State
Poland	Read-Gene S.A.	Grzepnica	West Pomerania

Sponsors (5)

Lead Sponsor	Collaborator
Read-Gene S.A.	IQ Pharma S.A., National Center for Research and Development, Poland, Vipharm S.A., West Pomeranian University of Technology

Country where clinical trial is conducted

Poland, 

References & Publications (67)

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* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of any new cancer	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.	within 60 months of the study
Secondary	Development of new breast cancer	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.	within 60 months of the study
Secondary	Proportion of any other cancers (besides breast cancers) at the end of 60 months	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.	within 60 months of the study

External Links

•   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