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

April 19, 2023 updated by: Lubinski Jan, Read-Gene S.A.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • West Pomerania
      • Grzepnica, West Pomerania, Poland, 72-003
        • Read-Gene S.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BRCA(+) Selenium deficiency
Placebo: 100 Supplement: 100
Dietary supplement: Selenium supplementation or placebo treatment
Patients from this group will receive selenium supplement to achieve optimal selenium level
Active Comparator: BRCA(+) Selenium excess
Diet modification: 500 Observation: 500
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.
Active Comparator: BRCA(-) Selenium deficiency
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
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
Active Comparator: BRCA(-) Selenium excess
Diet modification: 1100 Observation: 1100
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.
Active Comparator: BRCA(+) Selenium excess, age > 50
Diet modification: 200 Observation: 200
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of any new cancer
Time Frame: 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.
within 60 months of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of new breast cancer
Time Frame: 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.
within 60 months of the study
Proportion of any other cancers (besides breast cancers) at the end of 60 months
Time Frame: 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.
within 60 months of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Read-Gene S.A.

Collaborators

National Center for Research and Development, Poland
IQ Pharma S.A.
West Pomeranian University of Technology
Vipharm S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INNOMED/I/16?NCBR/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We still did not collect all the required participants. It is hard to tell that the data could be useful later on.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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