Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Rabin Medical Center; Rambam Health Care Campus; Sheba Academic Medical Center Hospital; Soroka Medical Center; Soroka University Medical Center
• Treatments: Aspirin

Criteria

Inclusion Criteria:

1. Male or female patients ≥ 18 years.

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. Provision of voluntary written informed consent.

Exclusion Criteria:

1. 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.

2. 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.

3. Current methotrexate use at a weekly dose of ≥ 15mg.

4. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma.

5. Existing clinically significant liver impairment.

6. Existing renal failure.

7. Confirmed active peptic ulcer disease within the previous three months.

8. Known bleeding diathesis or concomitant warfarin therapy.

9. Inability to comply with study procedures and agents.

10. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years.

11. Women who are breastfeeding.

12. Any significant medical illness that would interfere with study participation.

• Previous use of aspirin for medicinal purposes does not exclude enrolment but duration and quantity need to be documented in detail