Phase IIa Study of Naproxen or Aspirin for Immune Effects and Cancer Prevention in Adults with Lynch Syndrome

What this Trial Is About

Researchers are studying the effects of naproxen and aspirin on the immune system in people with Lynch Syndrome, a condition that increases the risk of colorectal cancer. This Phase IIa clinical trial aims to understand how these drugs affect the number and types of immune cells, especially T cells, in the normal colon tissue. The study also evaluates impacts on gene expression, immune cell distribution, polyp burden, and the safety of these treatments in participants with Lynch Syndrome. Participants are randomly assigned to take either naproxen or aspirin capsules once daily, at about the same time each day, for an average of one year. The trial includes two treatment groups one receiving naproxen and the other aspirin. Participants undergo two lower gastrointestinal endoscopies with biopsies, spaced 12 months apart, to assess changes in the colon tissue. The study also monitors the microbiome in normal mucosa, stool, and periodontal areas. During the trial, participants will have regular assessments including tissue biopsies, blood tests, and symptom evaluations. Researchers will measure the abundance of immune cells and gene activity in the colon and endometrium. The study tracks safety and side effects throughout. Participants must agree to follow study rules, including avoiding aspirin or similar drugs outside the study and undergoing yearly colonoscopies. The total involvement lasts about one year, with close monitoring by the research team.

A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome