Oral topical cyclo-oxygenase 2 inhibitors (COX2-1) mouthwash for the treatment of oral dysplasia

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network, Ear; Subtopic: Head and Neck Cancer, Ear (all Subtopics); Disease: Head and Neck, Ear, nose & throat; Cancer; Other diseases of lip and oral mucosa

• Registration Number: ISRCTN31503555
• Lead Sponsor: Coventry University Hospital (UK)

Brief Summary

2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22731119 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-23
• Study Completion: 2011-10-03
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel 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

Name	Time	Method
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).