Topic: National Cancer Research Network, Ear
Conditions
Interventions
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.
Sponsors
Coventry University Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
England, United Kingdom
Outcome results
None listed