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Trial record 65 of 11652 for:    Oral Cancer

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

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.

Condition or disease Intervention/treatment Phase
Oral Cancer Dietary Supplement: Watercress Juice Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable. [ Time Frame: 8 hours ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790204


Locations
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United States, District of Columbia
Georgetown Clinical Research Unit
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Fung-Lung Chung, Ph.D. Lombardi Comprehensive Cancer Center

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01790204     History of Changes
Other Study ID Numbers: R01CA1000853
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: November 2013

Keywords provided by Georgetown University:
mutant p53
watercress
Phenethyl isothyocyanate
oral cells of smokers

Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases