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

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

Interventions

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.

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

Sponsors & Collaborators

• National Center for Research and Development, Poland

  collaborator OTHER

• IQ Pharma S.A.

  collaborator UNKNOWN

• West Pomeranian University of Technology

  collaborator UNKNOWN

• Vipharm S.A.

  collaborator UNKNOWN

• Read-Gene S.A.

  lead OTHER

Principal Investigators

• Jan Lubiński, MD, PhD · Read-Gene S.A.

• Cezary Cybulski, MD, PhD · Read-Gene S.A.

• Jacek Gronwald, MD, PhD · Read-Gene S.A.

• Tomasz Huzarski, MD, PhD · Read-Gene S.A.

• Anna Jakubowska, MD, PhD

• Antoni Morawski, PhD

• Ewa Stachowska, PhD · Read-Gene S.A.

• Edyta Balejko, PhD

• Karolina Ertmańska, PhD

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• Poland