Our new study,Cancer Prevention Project 3, will focus first on
finding the right dose of aspirin for people with a mismatch repair
gene defect, the underlying cause of Lynch syndrome. The
centerpiece will be a new Randomised Controlled Trial where we
invite 3000 people who have Lynch syndrome to provide some blood
and saliva before receiving a supply of enteric coated aspirin
tablets. They will take three tablets each day. At
least one will be a placebo tablet and at least one will contain
aspirin. We will keep a secret code so that no-one will know
for five years whether they are taking 100mg, 300 mg or 600mg of
aspirin per day. The blood and saliva samples will help us to
investigate whether some people react differently and also whether
we can predict using blood markers who will develop cancers in the
future. Anyone who takes part will need to be part of a
national or regional registry which can provide careful follow-up
to report side effects and provide detailed information about any
cancers or polyps which are found on routine checkups.
Any trial which involves giving people tablets, even something
as well known as aspirin, takes many months to set up because we
need lots of staff which means we need a major research grant and
we also need ethics clearance and permission from the trial
regulators. The new European Clinical Trials system is very
expensive and imposes strict controls to ensure patient safety but
it makes simple trials of things like aspirin very difficult.
We will run this part of CaPP3 in selected centres where they
can cope with the regulation and provide the long term information
most easily. Apart from UK centres, this group will include
national registries in Finland, Denmark, Germany and the
Netherlands and the state registry in Victoria, Australia.
Other centres may be able to join this part of the study if
we can raise the funds.
The second part will involve people with Lynch syndrome from
anywhere else in the world. We want to try a revolutionary
new way to do clinical trials. Anyone with Lynch syndrome
will be able to sign up direct on our secure website.
Provided they can get the agreement of their local doctors to
support them by providing follow up information, and providing they
agree to take the same daily dose of aspirin for the next five
years we will put them into the random draw and tell them whether
they should take a mini-aspirin (usually 75-100mg depending on
local supplies), a standard aspirin (300-325mg) or two standard
aspirin (600-650mg). We know the bigger dose works well but
we don't know if the smaller doses will be as effective. It
will be interesting to see if we can set up a clinical trial in
this way and collect the information we need to care for the next
generation in the best way. As we can now recommend aspirin for all
people with Lynch syndrome, your doctor should be willing to
prescribe the aspirin supply. In some countries its cheaper
to buy the aspirin direct at the pharmacy but its important your
doctor knows you are on regular aspirin.
People who started in CAPP2 have a big part to play. We
need them to carry on telling us what happens to them for the years
to come and hopefully also allow us to study their gene patterns to
see how they react to aspirin as we think we may be able to explain
why some people develop cancers even though they were taking
aspirin. We already have regular contact with many people in
CAPP2 but we would very much like to hear from everyone who took
part, even if they dropped out early. Like everyone else,
they need to decide whether to take aspirin and how much to
take. Anyone who wants to know whether they were on aspirin
or placebo can either contact us direct via the CaPP3 website or
contact their local CAPP2 trial doctor and we can pass the
information through them.