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临床试验/NCT01790204
NCT01790204已完成1 期

A Study of the Effects of PEITC on Oral Cells With Mutant p53

Georgetown University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
55
试验地点
2
主要终点
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.

研究概览

简要总结

The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral cells will contain measurable levels of mutant p53. The participants will consume watercress juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral cells. This depletion could lead to a possible clinical application of this compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Heavy Smoker
  • Between the ages of 20 and 65
  • Must be able to show proof of citizenship or residency of the United States
  • Able to sign and understand a standard consent form

排除标准

  • Pregnant or Breast-feeding
  • Having any of the following medical conditions:
  • Leukoplakia
  • Oral Lesions
  • Any oral disease that causes sores, ulcerations, irritations, etc.
  • Stomach or Intestinal Ulcers
  • IBS (Irritable Bowel Syndrome)
  • Kidney Disease
  • Allergies to watercress or other Cruciferous Vegetables
  • Strict Vegetarians or Vegans
  • Religious Consumers of Watercress or other Cruciferous Vegetable Juices
  • On any of the following medications:
  • Chlorzoxazone (Parafon Forte, Paraflex)
  • Water Pills/Diuretics (Thiazide or Lasix)
  • Warfarin (Coumadin)
  • Vitamin K supplements
  • H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
  • Proton Pump Inhibitor (Prevacid)
  • Antibiotics
  • Diabetic Medications (Insulin)
  • Inhaled Bronchodilator
  • Oral Steroids (Prednisone, Medrol)
  • Inhaled Steroids (Flonase)
  • Raloxifene or Tamoxifen
  • Thyroid Hormone Replacement

结局指标

主要结局

Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.

时间窗: 8 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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