Mesalamine for Colorectal Cancer Prevention Programme in Lynch syndrome (MesaCAPP): a multicentre, multinational, randomised, two-arm, double-blind, phase II clinical study with mesalamine or placebo in carriers with Lynch syndrome - a study protocol.

ABSTRACT:

Introduction

Lynch syndrome (LS) carriers have a 20-46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA's efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.

Methods and analysis

This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared w

SUBMITTER: Backman AS 

PROVIDER: S-EPMC12598961 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature