Precancerous ConditionPhase 1NCT01238185
Aspirin Mouthwash in Treating Patients With Oral Leukoplakia
A Phase 1 study testing acetylsalicylic acid, gene expression analysis and protein expression analysis in people with Precancerous Condition, run by Institute of Head and Neck Studies and Education, United Kingdom at 2 sites in United Kingdom.
Trial summary
RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash in treating patients with oral leukoplakia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Precancerous Condition
- What is being tested?
- acetylsalicylic acid, gene expression analysis and protein expression analysis
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2010to Oct 2011
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinically diagnosed oral leukoplakia requiring a tissue biopsy for histological diagnosis
- Attending the outpatient clinic
PATIENT CHARACTERISTICS:
- Not nursing
- No known or suspected sensitivity to aspirin or other nonsteroidal anti-inflammatory drugs
- No diagnosis of asthma or angioedema
- No contraindications, including any of the following:
- Active peptic ulceration or a history of peptic ulceration
- Hemophilia or a history of bleeding disorders
- Gout or a history of gout
PRIOR CONCURRENT THERAPY:
- No concurrent regular use of aspirin for heart disease or other reasons
- No other concurrent nonsteroidal anti-inflammatory drugs
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Birmingham
Birmingham, England, B15 2TT
Institute of Head and Neck Studies and Education
Coventry, England, CV2 2DX
About this study
Official title: Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia
RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash in treating patients with oral leukoplakia.
Read the detailed description
OBJECTIVES:
- To determine if oral topical acetylsalicylic acid mouthwash achieves modulation of COX-1, COX-2, and prostaglandin in oral dysplasia tissues in patients with oral leukoplakia.
- To determine if this drug achieves alteration of histopathology and gene and protein expression in tissue.
- To determine if this drug achieves aspirin-induced tissue changes relating to altered tumor biology.
- To assess local and general tolerability and safety of this drug in these patients.
OUTLINE: All patients undergo tissue biopsy for histological diagnosis. Patients without a histological diagnosis of precancerous oral dysplasia undergo routine follow-up. Patients with a histological diagnosis of precancerous oral dysplasia are sequentially allocated to 1 of 4 treatment groups.
- Group 1: Patients receive acetylsalicylic acid mouthwash (one 75 mg tablet dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 2: Patients receive acetylsalicylic acid mouthwash (two 75 mg tablets of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 3: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 4: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) three times daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
At the time of definitive surgical excision, the patient is asked to gargle with the last dose of acetylsalicylic acid mouthwash just before being anesthetized. A small biopsy of the dysplasia lesion is taken and examined for immediate effects of the acetylsalicylic acid mouthwash on the dysplasia lesion. The surgically excised tissue is treated in the same way as the initial biopsy tissue (i.e., half being used for routine histology to confirm the diagnosis and the other half for research purposes). Tissue samples are analyzed via enzyme immunosorbent assay, qRT-PCR, immunoblotting, ELISA, immunohistochemistry, gene array analysis, and microvessel density analysis.
Patients complete a questionnaire assessing local and general tolerability as well as adverse effects during the period of use of the mouthwash.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
- Conditions
- Precancerous Condition
- Being tested
- acetylsalicylic acid, gene expression analysis, protein expression analysis, laboratory biomarker analysis, questionnaire administration
- Keywords
- oral leukoplakia
- Medical subject headings
- Precancerous Conditions, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
gene expression analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PGE2 levels as assessed by enzyme immunosorbent assay
COX-1 and COX-2 mRNA as assessed by qRT-PCR
COX-1 and COX-2 protein expression as assessed by immunohistochemistry and quantified by immunoblotting to determine whether COX inhibition in oral dysplasia tissues is actually possible by use of the mouthwash formulation
Secondary outcomes (5)
Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen
Tolerability and possible oral and other adverse effects using a questionnaire
VEGF mRNA expression as assessed by qRT-PCR
Protein expression as assessed by ELISA and immunohistochemistry for VEGFA
Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Head and Neck Studies and Education, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Hisham Mehanna, MD, Principal investigator, Institute of Head and Neck Studies and Education, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238185
- Sponsor's protocol ID
- INHANSE-ASPOD
- Other IDs
- CDR0000688122, ISRCTN31503555, EU-21083
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia
- ClinicalTrials.gov ID
- NCT01238185
- Acronym / sponsor ID
- INHANSE-ASPOD
- Conditions
- Precancerous Condition
- Keywords
- oral leukoplakia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Head and Neck Studies and Education, United KingdomUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 2010 (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.
RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash in treating patients with oral leukoplakia.
Detailed description
OBJECTIVES:
- To determine if oral topical acetylsalicylic acid mouthwash achieves modulation of COX-1, COX-2, and prostaglandin in oral dysplasia tissues in patients with oral leukoplakia.
- To determine if this drug achieves alteration of histopathology and gene and protein expression in tissue.
- To determine if this drug achieves aspirin-induced tissue changes relating to altered tumor biology.
- To assess local and general tolerability and safety of this drug in these patients.
OUTLINE: All patients undergo tissue biopsy for histological diagnosis. Patients without a histological diagnosis of precancerous oral dysplasia undergo routine follow-up. Patients with a histological diagnosis of precancerous oral dysplasia are sequentially allocated to 1 of 4 treatment groups.
- Group 1: Patients receive acetylsalicylic acid mouthwash (one 75 mg tablet dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 2: Patients receive acetylsalicylic acid mouthwash (two 75 mg tablets of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 3: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
- Group 4: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) three times daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
At the time of definitive surgical excision, the patient is asked to gargle with the last dose of acetylsalicylic acid mouthwash just before being anesthetized. A small biopsy of the dysplasia lesion is taken and examined for immediate effects of the acetylsalicylic acid mouthwash on the dysplasia lesion. The surgically excised tissue is treated in the same way as the initial biopsy tissue (i.e., half being used for routine histology to confirm the diagnosis and the other half for research purposes). Tissue samples are analyzed via enzyme immunosorbent assay, qRT-PCR, immunoblotting, ELISA, immunohistochemistry, gene array analysis, and microvessel density analysis.
Patients complete a questionnaire assessing local and general tolerability as well as adverse effects during the period of use of the mouthwash.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| acetylsalicylic acid | Drug | – |
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
PGE2 levels as assessed by enzyme immunosorbent assay
COX-1 and COX-2 mRNA as assessed by qRT-PCR
COX-1 and COX-2 protein expression as assessed by immunohistochemistry and quantified by immunoblotting to determine whether COX inhibition in oral dysplasia tissues is actually possible by use of the mouthwash formulation
5 secondary outcomes
Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen
Tolerability and possible oral and other adverse effects using a questionnaire
VEGF mRNA expression as assessed by qRT-PCR
Protein expression as assessed by ELISA and immunohistochemistry for VEGFA
Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays
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 12 Aug 2013.
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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.
Hisham Mehanna, MD principal investigator
Institute of Head and Neck Studies and Education, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acetylsalicylic acid, gene expression analysis and protein expression analysis in people with Precancerous Condition, run by Institute of Head and Neck Studies and Education, United Kingdom at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 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.
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?
PGE2 levels as assessed by enzyme immunosorbent assay. The study lists 3 primary outcomes in all. 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 12 Aug 2013.