Plain English Summary
Trial website
Additional identifiers
EudraCT number
2007-003292-40
ClinicalTrials.gov number
NCT01238185
Protocol/serial number
6070
Study information
Scientific title
Oral topical cyclo-oxygenase 2 inhibitors (COX2-1) mouthwash for the treatment of oral dysplasia: a pilot non-randomised interventional proof of concept study
Acronym
ASPOD
Study hypothesis
Pilot study assessing the potential role of aspirin in treating oral dysplasia.
Ethics approval
West Midlands REC approved on the 24th September 2009 (ref: 08/H1208/49)
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network, Ear; Subtopic: Head and Neck Cancer, Ear (all Subtopics); Disease: Head and Neck, Ear, nose & throat
Intervention
Group 1: Standard dispersible tablets of aspirin 75 mg (BNF) and be instructed to disperse one tablet thoroughly in one glass of 250 ml of water and use as mouthwash for 60 seconds twice a day.
Group 2: Two standard dispersible tablets of aspirin 75 mg (BNF) and will be instructed to dissolve the two tablets thoroughly in one glass of 250 ml of water and use as mouthwash for 60 seconds twice a day.
Group 3: Standard dispersible tablets of aspirin 300 mg (BNF) and be instructed to disperse one tablet thoroughly in one glass of 250 ml of water and use as mouthwash for 60 seconds twice a day.
Group 4: Standard dispersible tablets of aspirin 300 mg (BNF) and be instructed to dissolve the one tablet thoroughly in one glass of 250 ml of water and use as mouthwash for 60 seconds three times a day.
Patients will use the mouthwash for 6 weeks until they return for their second biopsy. Follow up is then whatever is required by the clinical team.
Study entry: registration only
Intervention type
Drug
Phase
Not Applicable
Drug names
Aspirin
Primary outcome measure
Level of COX expression, prostaglandin level and change in histological grade measured pre- and post-treatment. Measurement of the primary outcome measures will only occur once all patients have been recruited to the study. Pre and post treatment biopsy samples (6 weeks apart) are snap frozen and stored at -80°C.
Secondary outcome measures
All biochemical measures for the secondary outcomes will be measured at the same time. The histological grade of the tissue will be made within 7 - 10 days of each biopsy being taken as is normal clinical practive for these lesions. The tolerability and side effects will be ascertained on the patients return for their second biopsy (6 weeks after commencing the Aspirin).
Overall trial start date
01/02/2010
Overall trial end date
03/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with clinically evident leukoplakia
2. Can attend follow up
3. Requiring biopsy and surgery
4. 18 years old or over, either sex
5. Able to give informed consent
6. Not known to be pregnant
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 40; UK sample size: 40
Participant exclusion criteria
1. Histologically confirmed cancer
2. Prior oral cancer
3. Patients on aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroid treatment
4. Current treatment of oral dysplasia with topical/systemic treatment
5. Active peptic ulcer disease
6. History of aspirin induced asthma, stomach ulcers or aspirin sensitivity
7. History of associated angioedema, urticaria or suspected aspirin allergy in the past
Recruitment start date
01/02/2010
Recruitment end date
03/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
Coventry University Hospital (UK)
Sponsor details
Clinical Sciences Research Institute
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C19677/A8556)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22731119
Publication citations
-
Results
Nankivell P, Dunn J, Langman M, Mehanna H, Feasibility of recruitment to an oral dysplasia trial in the United Kingdom., Head Neck Oncol, 2012, 4, 40, doi: 10.1186/1758-3284-4-40.