Finding the best dose of aspirin to prevent Lynch Syndrome cancers

Not Applicable

• Conditions: ynch syndrome; Cancer

• Registration Number: ISRCTN16261285
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-14
• Last Update Posted: 22 April 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Aged 18 years or over
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 (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. 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of Lynch Syndrome Cancers is determined throughout the study and during 10 years following the end of the study.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration