Condition category
Cancer
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
08/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Paul Nankivell

ORCID ID

Contact details

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

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 measures

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

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

http://www.uhcw.nhs.uk/

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

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22731119

Publication citations

  1. 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.

Additional files

Editorial Notes