ASPOD study

• Research type

  Research Study

• Full title

  Oral topical cyclo-oxygenase inhibitor(aspirin) mouthwash for treatment of oral dysplasia

• IRAS ID

  2360

• Contact name

  Hisham Mehanna

• Sponsor organisation

  University Hospitals Coventry and Warwickshire NHS trust

• Eudract number

  2007-003292-40

• ISRCTN Number

  N/A

• Research summary

  This study aims to assess whether Aspirin mouthwash has any benefit as a treatment of oral pre-cancerous lesions (oral dysplasia) which carries a risk of progressing to oral cancer. Currently, the most effective treatment is surgical removal with a risk of recurrence. Therefore non-surgical treatments that cure dysplasia and/or prevent its transformation to cancer are much needed.Non-selective cyclo-oxygenase inhibitors are a group of drugs (that include Aspirin) that have been found to reduce the risk of cancers in other sites in the digestive tract. Further, receptors for these drugs have been found in increased numbers in oral dysplasia and oral cancer tissue. This has given rise to the concept that these receptors could be modulated by drugs that flunce their activity.In this study we aim to use Aspirin in a mouthwash form to evaluate its effects on oral dysplasia lesions. Patients diagnosed with oral dysplasia lesions who will require surgical removal of their lesion will be asked to take part. If they agree to participate, they will be asked to use the mouthwash two to three times a day, in the six week period that they are waiting to have the surgical removal. They will then have the surgical removal of their oral dysplasia lesion as routine. Patients are asked to keep a diary of any symptoms or side effects that they may develop. They are asked to contact the researcher if they feel any of the symptoms are severe.The tissue obtained from the surgical removal will then be subjected to a series of histological, biochemical and molecular biological tests to look for any effects of the Aspirin mouthwash.Positive results from this study will facilitate the setting up of a larger study to further evaluate the use of Aspirin mouthwash in the treatment of oral dysplasia.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/49

• Date of REC Opinion

  23 Feb 2009

• REC opinion

  Further Information Favourable Opinion