None listed
Conditions
Brief summary
This study will focus on finding the right dose of aspirin for cancer prevention in people with a mismatch repair (MMR) gene defect, the underlying cause of Lynch syndrome, also known as HNPCC (Hereditary Non-Polyposis Colon Cancer). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed hereditary gene defect in one of the mismatch repair genes; MSH2, MLH1, PMS2 or MSH6 manifesting a classic Lynch syndrome phenotype. Study details All study participants will take daily aspirin tablets for duration of two years but will be allocated by chance to one of three different doses (100mg, 300 mg or 600mg). Study investigators will not know which dose any participant is given and you will not be aware of the dose that you are taking. We will then measure number of participants that develop cancers over 5 years. Our previous study CaPP2 showed that 600mg of aspirin was effective at reducing the risk of cancer in people with Lynch Syndrome and in this study (CaPP3) we would like to determine if 100mg and 300mg of aspirin will be as effective as the higher dose. Taking lower doses of aspirin carries lower risk of side effects such as stomach bleeding occurring.
Interventions
Enteric-coated aspirin 100mg, 300mg or 600mg blinded dose daily for a duration of 2 years.
Oral tablet, twice a day administration. Unused drug blister pack will need to be returned every 6 months for reconciliation and monitoring adherence.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18. 2. 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. 3. Able to swallow tablets. 4. Willing to complete the CaPP3 consent process as described in the patient information sheet.
Exclusion criteria
1. Regular use of a non-steroidal anti-inflammatory agent on a prescription and/or long-term basis. Regular is defined as > 3 doses per week, for more than 3 months in the last 3 years. 2. Previous regular use of aspirin at a daily dose of 150mg or less does not exclude enrolment but duration and quantity need to be documented in detail. More than 3 months use of > 150mg or more per day in the last 3 years is an exclusion 3. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma. 4. Existing clinically significant liver impairment. 5. Existing renal failure. 6. Confirmed active peptic ulcer disease within the previous three months. 7. Known bleeding diathesis or concomitant anticoagulant therapy. 8. Inability to comply with study procedures and agents. 9. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years. 10. Women who are breastfeeding. 11. Any significant medical illness that would interfere with study participation. (If hypertension is discovered, the participant should be advised to have this treated before commencing trial medication). 12. Participation in the previous CAPP2 study will not exclude patients from this study, apart from the small number recruited less than 10 years previously
Outcome results
None listed