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

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ClinicalTrials.gov Identifier: NCT01790204
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date  ICMJE February 11, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date March 23, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable. [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of PEITC on Oral Cells With Mutant p53
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Oral Cancer
Intervention  ICMJE Dietary Supplement: Watercress Juice
The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Study Arms  ICMJE Experimental: Watercress Juice
The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Intervention: Dietary Supplement: Watercress Juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)
55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or Breast-feeding
  • Having any of the following medical conditions:
  • Leukoplakia
  • Oral Lesions
  • Cancer
  • 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)
  • Lithium
  • Water Pills/Diuretics (Thiazide or Lasix)
  • Warfarin (Coumadin)
  • Vitamin K supplements
  • H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
  • Proton Pump Inhibitor (Prevacid)
  • Digoxin
  • Antibiotics
  • Diabetic Medications (Insulin)
  • Inhaled Bronchodilator
  • Oral Steroids (Prednisone, Medrol)
  • Inhaled Steroids (Flonase)
  • Raloxifene or Tamoxifen
  • Thyroid Hormone Replacement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01790204
Other Study ID Numbers  ICMJE R01CA1000853
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fung-Lung Chung, Ph.D. Lombardi Comprehensive Cancer Center
PRS Account Georgetown University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP