Phase 1/Phase 2
20 Years
65 Years
20 Years
65 Years
Open (Enrolling)
Both
Oral Cancer
Both
Oral Cancer
Trial Information
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
Outcome Time Frame:
8 hours
Safety Issue:
No
Principal Investigator
Fung-Lung Chung, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lombardi Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
R01CA1000853
NCT ID:
NCT01790204
Start Date:
March 2012
Completion Date:
February 2013
Related Keywords:
- Oral Cancer
- mutant p53
- watercress
- Phenethyl isothyocyanate
- oral cells of smokers
- Mouth Neoplasms
Name | Location |
|---|---|
| Georgetown Clinical Research Unit | Washington, District of Columbia 20007 |
