Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Development of any new cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA)
- •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
排除标准
- •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
- •Age <40 years except for women that have been previously diagnosed with breast cancer
- •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)
研究组 & 干预措施
BRCA(-) Selenium excess
Diet modification: 1100 Observation: 1100
干预措施: Diet modification (Other)
BRCA(+) Selenium excess, age > 50
Diet modification: 200 Observation: 200
干预措施: Diet modification (Other)
BRCA(+) Selenium deficiency
Placebo: 100 Supplement: 100
干预措施: Selenium supplementation or placebo treatment (Dietary Supplement)
BRCA(+) Selenium excess
Diet modification: 500 Observation: 500
干预措施: Diet modification (Other)
BRCA(-) Selenium deficiency
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
干预措施: Selenium supplementation or placebo treatment and diet modification (Other)
结局指标
主要结局
Development of any new cancer
时间窗: 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.
次要结局
- 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)
研究者
Lubinski Jan
MD, PhD
Read-Gene S.A.