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临床试验/NCT01022333
NCT01022333Unknown1 期

The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

Women's College Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
1 期
入组人数
300
试验地点
2
主要终点
Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation

研究概览

简要总结

Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Carriers of a mutation in the BRCA1 gene
  • Non-carriers of a mutation in the BRCA1 gene who come from a family with a BRCA1 mutation (a family in which at least one individual has tested positive for a BRCA1 mutation)
  • Can participate after being free of DIM supplementation for one month

排除标准

  • Have a personal history of cancer
  • Currently pregnant or breast-feeding

结局指标

主要结局

Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation

时间窗: 6 months

次要结局

  • Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation(6 months)

研究者

申办方类型
Other

研究点 (2)

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