Health TrialsbyHealthPanel

Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

ConditionLynch Syndrome I (Site-specific Colonic Cancer)
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    Aspirin (acetylsalicylic acid) has a marketing approval for use in the EU and is widely available as an over the counter medicine. However it is not being used within its licensed indication and the aspirin (at any dose in this study) will be treated as an investigational medicinal product (IMP). Tablets will be provided as enteric-coated 100mg or 300mg tablets for oral use. All patients will receive at least some dose of aspirin but blinding to the actual dose will be achieved by the use of 'dummy' tablets using the same excipients as in the active formulation of the aspirin minus the active ingredient. The aspirin and dummy tablets should be stored at room temperature below 25⁰C in a dry place.

Treatment groups

1,800 Participants
are divided into 3 treatment groups
Group A: 100 mg daily aspirinActive comparator 1 intervention
Group B: 300 mg daily aspirinActive comparator 1 intervention
Group C: 600 mg daily aspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer

The number of new primary mismatch repair deficient cancers ("Lynch syndrome cancers") at 5 years which develop in participants who remain on prescribed treatment for a minimum of 2 years.

Time frame
5 years

Secondary outcomes

1

Overall cumulative of new colorectal cancers incidence rates after 5 years

The number of new colorectal cancers at 5 years which develop in participants who remain on prescribed treatment for a minimum of 2 years.

Time frame
5 years
2

Overall cumulative of new endometrial cancers incidence rates after 5 years

The number of new endometrial cancers at 5 years which develop in participants who remain on prescribed treatment for a minimum of 2 years.

Time frame
5 years
3

Overall cumulative of new new cancers of all types incidence rates after 5 years

• The number of new cancers of all types at 5 years which develop in participants who remain on prescribed treatment for a minimum of 2 years.

Time frame
5 years
4

Overall cumulative of changes in the titre of frameshift peptide antibodies after 2 & 5 years

Changes at 2 \& 5 years in the titre of frameshift peptide antibodies from commencement of the prescribed treatment.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: