Oral topical cyclo-oxygenase 2 inhibitors (COX2-1) mouthwash for the treatment of oral dysplasia
| ISRCTN | ISRCTN31503555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31503555 |
| ClinicalTrials.gov (NCT) | NCT01238185 |
| Clinical Trials Information System (CTIS) | 2007-003292-40 |
| Protocol serial number | 6070 |
| Sponsor | Coventry University Hospital (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref: C19677/A8556) |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 29/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mr Paul Nankivell
Scientific
Scientific
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ASPOD |
| Study objectives | Pilot study assessing the potential role of aspirin in treating oral dysplasia. |
| Ethics approval(s) | West Midlands REC approved on the 24th September 2009 (ref: 08/H1208/49) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Aspirin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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). |
| Completion date | 03/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 13 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 03/10/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/06/2012 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 20/11/2013 | 29/03/2022 | No | Yes |
Editorial Notes
29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
