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

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ClinicalTrials.gov Identifier: NCT04014283
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
National Center for Research and Development, Poland
IQ Pharma S.A.
West Pomeranian University of Technology
Vipharm S.A.
Information provided by (Responsible Party):
Lubinski Jan, Read-Gene S.A.

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Dietary Supplement: Selenium supplementation or placebo treatment Other: Diet modification Other: Selenium supplementation or placebo treatment and diet modification Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Investigator)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
Actual Study Start Date : October 2014
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014283


Contacts
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Contact: Jan Lubiński, MD, PhD 91 433 42 56 ext +48 lubinski@pum.edu.pl

Locations
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Poland
Read-Gene S.A. Recruiting
Grzepnica, West Pomerania, Poland, 72-003
Contact: Jan Lubiński, MD, PhD    91 433 42 56 ext +48      
Sponsors and Collaborators
Read-Gene S.A.
National Center for Research and Development, Poland
IQ Pharma S.A.
West Pomeranian University of Technology
Vipharm S.A.
Investigators
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Principal Investigator: Jan Lubiński, MD, PhD Read-Gene S.A.
Study Chair: Cezary Cybulski, MD, PhD Read-Gene S.A.
Study Chair: Jacek Gronwald, MD, PhD Read-Gene S.A.
Study Chair: Tomasz Huzarski, MD, PhD Read-Gene S.A.
Study Chair: Anna Jakubowska, MD, PhD
Study Chair: Antoni Morawski, PhD
Study Chair: Ewa Stachowska, PhD Read-Gene S.A.
Study Chair: Edyta Balejko, PhD
Study Chair: Karolina Ertmańska, PhD

Additional Information:
Publications:
Lubiński J. (red.), Genetyka Kliniczna Nowotworów 2015; ISBN 978-83-61350-95-8
Petkova-Marinova T, B Ruseva, B Atanasova, B Paneva-Barzashka, P Laleva and V Petrov; Relationships between parameters of iron metabolism and serum concentrations of copper and selenium in women with normal and problem pregnancies; Merit Research Journal of Medicine and Medical Sciences (ISSN: 2354-323X) Vol. 4(8) pp. 406-414, August, 2016
Polish Ministry of Health, Programme for diagnostics and management of families with hereditary predisposition to breast and ovarian cancers

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Responsible Party: Lubinski Jan, MD, PhD, Read-Gene S.A.
ClinicalTrials.gov Identifier: NCT04014283     History of Changes
Other Study ID Numbers: INNOMED/I/16?NCBR/2014
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We still did not collect all the required participants. It is hard to tell that the data could be useful later on.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lubinski Jan, Read-Gene S.A.:
Selenium
Supplement
Prevention
Females
Risk

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances