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临床试验/NCT00910884
NCT00910884Unknown不适用

Stage IV Breast Cancer Gene Expression Control Using Micro-Trace and Plant Extracted Natural G.R.A.S. (Generally Accepted As Safe), Compounds in Adjunct Therapy Alongside Conventional Cancer Protocols

Brabant Research1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Suppression of cancer genetic pathways to reproduction.

研究概览

简要总结

RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers.

PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.

详细描述

OBJECTIVES:

To utilize multiple naturally-occurring bioalkaloids, bioactive "compounds of interest" from multiple sources, to influence prostate, breast, and uterine cancer pathways in cancer patients and cancer patients in remission. Other cancer types may be applicable.

To utilize specific naturally-occurring bioalkaloids and bioactive "compounds of interest" to suppress cancer proliferation-stimulation/growth activities induced by normal cancer metabolism including environmental estrogen impact, estrogen-mimicking compounds, estrogen-influencing and testosterone-type compounds.

To utilize DNA interaction with proliferating cancer cells via intercalation, which has a binding impact activity that then impairs DNA polymerase furthering DNA strand breakage and complete apoptosis. In addition, these bioactive compounds through intercalation, prevent cancer-cell DNA strand breakage from re-connection and repair, (limitlessness) while depleting nuclear topoisomerase, the enzyme also targeted by a number of conventional chemotherapy routes. Finally; a number of the bioalkaloids binds to cancer telomeres capping them at specific number or reducing them to "one and done."

Natural GRAS compounds, in previous studies that background this research, reduced secondary bonding of TMPRSS2-ERG fusing affecting testosterone & estrogen hormone influence in cell proliferation. Variant mRNAs of, for example, the TMPRSS2-ERG fusing pathway were affected whereas normalized mRNAs in all other cells were not, a mechanism and chemistry not readily understood.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Suppression of cancer genetic pathways to reproduction.

时间窗: 6 months

suppress cancer cell proliferation

Monitor normal metabolic function while measuring cancer-marker levels.

时间窗: 6 months

metabolic function testing

Reduction of secondary bonding of TMPRSS2-ERG fusing using, among other modes of action, DPPH radical-scavenging activity

时间窗: 6 months

Monitor levels

Utilize GRAS plant extracted compounds for suppression of cancer-cell replication.

时间窗: 12 months

Using adjunct therapy to augment and increase efficacy of conventional cancer treatments

次要结局

未报告次要终点

研究者

发起方
Brabant Research
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Richard Lasker

Director

Brabant Research

研究点 (1)

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