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

NCT04014283 | Unknown DMC

• 1 other identifier: INNOMED/I/16?NCBR/2014
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Selenium; Supplement; Prevention; Females; Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of new breast cancer

  within 60 months of the study

• Proportion of any other cancers (besides breast cancers) at the end of 60 months

  within 60 months of the study

Study Arms (5)

BRCA(+) Selenium deficiency

ACTIVE COMPARATOR

Placebo: 100 Supplement: 100

Dietary Supplement: Selenium supplementation or placebo treatment

BRCA(+) Selenium excess

ACTIVE COMPARATOR

Diet modification: 500 Observation: 500

Other: Diet modification

BRCA(-) Selenium deficiency

ACTIVE COMPARATOR

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

Other: Selenium supplementation or placebo treatment and diet modification

BRCA(-) Selenium excess

ACTIVE COMPARATOR

Diet modification: 1100 Observation: 1100

Other: Diet modification

BRCA(+) Selenium excess, age > 50

ACTIVE COMPARATOR

Diet modification: 200 Observation: 200

Other: Diet modification

Interventions

Selenium supplementation or placebo treatment DIETARY_SUPPLEMENT

Patients from this group will receive selenium supplement to achieve optimal selenium level

BRCA(+) Selenium deficiency

Diet modification OTHER

Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.

BRCA(+) Selenium excess; BRCA(+) Selenium excess, age > 50; BRCA(-) Selenium excess

Selenium supplementation or placebo treatment and diet modification OTHER

In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood

BRCA(-) Selenium deficiency

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Sub-group I - BRCA1 mutation carriers
• Carrier-status of BRCA1 mutation
• Age \>20 years
• Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment
• Be able to give information consent and sign an informed consent form
• Be willing to comply with all of the study procedures as per the protocol
• Be willing to inform researchers about current or any new pregnancy
• Sub-optimal Se level in the blood
• Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations
• Age ≥40 years
• Age ≥20 years for women that have been diagnosed previously with breast cancer
• Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1)
• No personal history of cancer except for breast cancer and non-melanoma skin cancers
• Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment
• Be able to give information consent and sign an informed consent form

You may not qualify if:

• Sub-group I - BRCA1 mutation carriers
• Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers
• Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment
• Current pregnancy or breast-feeding
• Optimal Se level in the blood
• Age \<20 years
• Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy
• 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
• Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers
• Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment
• Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1)
• Presence of BRCA1 mutation
• Current pregnancy or breast-feeding
• Optimal Se level in the blood

Sponsors & Collaborators

• Read-Gene S.A.: lead
• National Center for Research and Development, Poland: collaborator
• IQ Pharma S.A.: collaborator
• West Pomeranian University of Technology: collaborator
• Vipharm S.A.: collaborator

Study Sites (1)

Read-Gene S.A.

Grzepnica, West Pomeranian Voivodeship, 72-003, Poland

Location

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Related 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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Jan Lubiński, MD, PhD

  Read-Gene S.A.

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2014
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

PL (1)