Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Lynch syndrome, either through a confirmed genetic mutation in one of the DNA mismatch repair genes (MLH1, MSH2/EPCAM, MSH6, or PMS2), or through a personal history of certain bowel growths or cancers that show signs of a mismatch repair problem without a clearly confirmed gene mutation.
• People who have no signs of active or returning cancer for at least the past 6 months.
• People who have finished any cancer treatment (such as surgery, chemotherapy, immunotherapy, hormone therapy, or radiation) at least 6 months ago.
• People who still have at least part of the lower colon and/or rectum intact, so that a camera exam of that area is possible.
• People who agree to have two lower bowel camera examinations with tissue samples taken, scheduled 12 months apart.
• People who agree to avoid aspirin, anti-inflammatory painkillers (such as ibuprofen), and related medications for the entire duration of the trial.
• People aged 18 or older.
• People who are in generally good physical health and able to carry out normal daily activities (confirm with trial site for specific fitness scoring details).
• People whose blood counts, kidney function, and liver function fall within acceptable ranges as determined by blood tests (confirm with trial site for specific values).
• Women who could become pregnant and who agree to use reliable contraception throughout the trial, and who agree to pregnancy tests at the start and before taking any study medication.
• People who are willing and able to give written informed consent and follow all trial requirements.
• People who agree to yearly standard colonoscopy screenings for the duration of the trial.

Who may not be able to join:

• People whose tumour testing shows a specific pattern of two genetic changes within the mismatch repair genes themselves (confirm with trial site for details).
• People who have regularly taken anti-inflammatory painkillers (NSAIDs or COX-inhibitors) for more than 3 days within the 2 weeks before the initial eligibility check — although people taking low-dose aspirin for heart protection (e.g., 81mg daily) may still be considered if willing to stop at least 7 days before starting the study medication.
• People who have had their entire colon and rectum surgically removed.
• People who have had a stomach or small bowel ulcer within the past 5 years.
• People with a history of gastrointestinal bleeding requiring a blood transfusion, a bowel perforation, or a bowel blockage (unless these were caused by a bowel cancer that has since been removed).
• People who have had a heart attack, stroke, coronary artery bypass surgery, or an invasive heart procedure within the past 5 years.
• People currently taking certain medications — including other anti-inflammatory painkillers, blood thinners, antiplatelet drugs, lithium, certain antidepressants, certain anti-seizure medications, certain antibiotics, or a number of other specific drugs — unless willing and able to stop these at least 7 days before starting the study medication (confirm the full medication list with the trial site).
• People with uncontrolled kidney problems or kidney failure.
• People with a known allergy to naproxen or aspirin.
• People with uncontrolled ongoing illness, such as active infection, uncontrolled high blood pressure, heart failure, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• Women who are pregnant, breastfeeding, or who could become pregnant but are unwilling to use reliable contraception during the trial.

Important: Always verify eligibility with the trial site directly before applying.