Oral CancerPhase 1/2NCT01790204
A Study of the Effects of PEITC on Oral Cells With Mutant p53
A Phase 1/2 study testing Watercress Juice in people with Oral Cancer, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Watercress Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or Breast-feeding
- Having any of the following medical conditions:
- Leukoplakia
- Oral Lesions
- Cancer
- Any oral disease that causes sores, ulcerations, irritations, etc.
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Clinical Research Unit
Washington D.C., District of Columbia, 20007
About this study
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.
- Conditions
- Oral Cancer
- Being tested
- Watercress Juice
- Keywords
- mutant p53, watercress, Phenethyl isothyocyanate, oral cells of smokers
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watercress JuiceDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Watercress Juice | Experimental | 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. Receives: Dietary Supplement: Watercress Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fung-Lung Chung, Ph.D., Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790204
- Sponsor's protocol ID
- R01CA1000853
- Status last verified
- Nov 2013
- First submitted
- 11 Feb 2013
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of PEITC on Oral Cells With Mutant p53
- ClinicalTrials.gov ID
- NCT01790204
- Acronym / sponsor ID
- R01CA1000853
- Conditions
- Oral Cancer
- Keywords
- mutant p53, watercress, Phenethyl isothyocyanate, oral cells of smokers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Watercress Juice | Experimental | Dietary Supplement: Watercress JuiceThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- Pregnant or Breast-feeding
- Having any of the following medical conditions:
- Leukoplakia
- Oral Lesions
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watercress JuiceThe 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 |
Primary outcome
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fung-Lung Chung, Ph.D. principal investigator
Lombardi Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Watercress Juice in people with Oral Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable. (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.