A study looking at using aspirin for pre cancerous white patches in the mouth - ASPOD
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at using aspirin to treat white patches (leukoplakia) in the mouth. White patches in the mouth are mostly harmless. But a small number may have changes in the cells (dysplasia) that if left untreated may develop into cancer. Doctors call these patches pre cancerous.
Doctors can treat these pre cancerous patches with surgery. But sometimes they come back. So doctors are always looking for new ways to treat them, stop them coming back and stop them becoming cancer.
We know from research that aspirin may help protect some people from certain types of cancer. The researchers think an aspirin mouthwash may help people with pre cancerous white patches in the mouth.
The aims of this study are to find out
- How aspirin mouthwashes affect pre cancerous white patches in the mouth
- How acceptable and safe it is for people to use aspirin mouthwashes
Who can enter
You cannot enter this trial if you
- Have, or have had, damage to the lining of your gullet (oesophagus), stomach or duodenum – this is called a peptic ulcer
- Have, or have had, a bleeding disorder
- Have, or have had, gout
- Are sensitive to aspirin or other non steroidal anti inflammatory drugs (NSAIDs)
- Are breastfeeding
This study will recruit 40 people from the University Hospitals of Coventry and Warwickshire NHS Trust.
There are 2 parts to this study. The first part is to see if the white patch in your mouth is pre cancerous. To do this the doctor will ask your permission to take a piece of tissue (biopsy) from the white patch. If it is pre cancerous, your doctor will invite you to take part in the 2nd part of the study.
In the second part of the study the researchers will ask you to use an aspirin mouthwash in the weeks before you have surgery.
There are 4 groups in this study. Neither you nor your doctor can choose which group you are in. The first person will be in group 1. The next person will be in group 2, and so on until there are 10 people in each group.
If you are in group 1, you have 1 tablet of 75mg aspirin dissolved in water as a mouthwash, twice a day.
If you are in group 2, you have 2 tablets of 75mg aspirin dissolved in water as a mouthwash, twice a day.
If you are in group 3, you have 1 tablet of 300mg aspirin dissolved in water as a mouthwash, twice a day.
If you are in group 4, you have 1 tablet of 300mg aspirin dissolved in water as a mouthwash, three times a day.
You dissolve the aspirin in 250ml of water. You rinse your mouth for at least 1 minute each time and spit it out, swallowing as little as possible.
On the day of your surgery you have the last mouthwash just before surgery.
If you choose to take part in this study there will be no delay to when you have surgery.
There are no extra hospital visits if you take part in this study.
The side effects of aspirin may include
- An allergic reaction causing breathing problems, swollen lips, tongue or face
- Skin rash
- Sore mouth or ulcers
Location of trialCLOSED
For more information
Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.
Cancer Research UK
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