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Phase 1/Phase 2
20 Years
65 Years
Open (Enrolling)
Both
Oral Cancer

Thank you

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