Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel-Aviv Sourasky Medical Center
About this trial
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).
Eligibility criteria
Qualifiers
Male or female patients ≥ 18 years.
Confirmed germline pathological variant in one of the mismatch repair genes; MSH2, MLH1, PMS2 or MSH6 or a 3' EPCAM deletion associated with MSH2 silencing or be a carriers of a constitutional epimutation manifesting a classic Lynch syndrome phenotype.
Able to swallow tablets.
Provision of voluntary written informed consent.
Disqualifiers
Regular use of a non-steroidal anti-inflammatory agent (except aspirin*) on a prescription and/or long-term basis. Regular is defined as > 3 doses per week.
Regular use of aspirin (> 3 doses per week or on a prescription basis) that cannot be replaced with any one of the randomised arms of the study followed by 100mg dose.
Current methotrexate use at a weekly dose of ≥ 15mg.
Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma.
Trial design
Treatments tested in this trial
- Aspirin
Treatment groups
1,800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Tel-Aviv Sourasky Medical Center
Lead sponsor
Rambam Health Care Campus
Collaborator
Rabin Medical Center
Collaborator
Soroka University Medical Center
Collaborator
Sheba Medical Center
Collaborator
Source ClinicalTrials.gov