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

ISRCTN	ISRCTN31503555
DOI	https://doi.org/10.1186/ISRCTN31503555
EudraCT/CTIS number	2007-003292-40
ClinicalTrials.gov number	NCT01238185
Secondary identifying numbers	6070

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

http://cancerhelp.cancerresearchuk.org/trials/a-study-using-aspirin-for-pre-cancerous-white-patches-mouth-ASPOD

Contact information

Mr Paul Nankivell
Scientific

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Study design	Non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/02/2010
Completion date	03/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 40; UK sample size: 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

England
United Kingdom

Study participating centre

Clifford Bridge Road

Coventry
CV2 2DX
United Kingdom

Sponsor information

Coventry University Hospital (UK)
Hospital/treatment centre

Clinical Sciences Research Institute
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom

Website	http://www.uhcw.nhs.uk/
"ROR"	https://ror.org/025821s54

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C19677/A8556)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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
Plain English results		20/11/2013	29/03/2022	No	Yes
HRA research summary			28/06/2023	No	No

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.