CaPP3

• Research type

  Research Study

• Full title

  A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

• IRAS ID

  141927

• Contact name

  John Burn

• Contact email

  john.burn@ncl.ac.uk

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2014-000411-14

• ISRCTN Number

  N/A

• Research summary

  Our previous trial CAPP2 showed that Lynch syndrome carriers who are at high risk of colorectal, endometrial and other cancers, took 2 aspirin (600mg) per day for at least two years their cancer risk at 5 years was reduced by 60%. Other recent research studies confirm this aspirin effect.
  The risks associated with aspirin are well known; annually about 1 in 1000 users develop ulcers and intestinal bleeding. The risk of gastrointestinal bleeding increases with dose of aspirin. Before recommending aspirin to people at high risk of cancer, we need to determine if low dose aspirin such as is used to prevent heart attacks and strokes is as effective as the 2 aspirin (600mg) used daily in CAPP2.
  In CaPP3 we need 3000 proven gene carriers affected by Lynch syndrome to answer this important question. To ensure reliable information about cancer occurrence and side effects is reported, the dose will be blinded. Everyone will take a mixture of real and dummy tablets. The three tablets each day will deliver either 600mg, 300mg, or 100mg of enteric coated aspirin. After 2 years on the blinded dose, participants will be given 100mg open label enteric coated aspirin until the last recruit reaches their fifth anniversary.
  We will be aiming to recruit from 23 UK genetics centres (26 sites). Drug packs will be delivered directly to the patient to save them travelling to collect the drug. They will be routinely followed up by an initial phone call at 3 months and then 6 monthly thereafter for the blinded phase. In the open label phase only yearly follow ups will be required. The aim is to balance adequate safety follow up whilst remaining mindful that patients are not “sick”, so minimising travelling to hospital and being in a clinical environment unnecessarily.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  14/NE/0103

• Date of REC Opinion

  15 May 2014

• REC opinion

  Further Information Favourable Opinion