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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

Backman, Ann Sofie ; Frank, Alexander ; Lindberg, Lars Joachim ; Ljungman, David ; Silander, Gustav ; Gustafsson, Rita J. LU ; Bozsó, Tünde ; Schmidt, Peter T. ; Ingre, Michael and Mittlbock, Martina , et al. (2025) In BMJ Open 15(11).
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... (More)

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 with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (<45 years vs ≥45 years), and assessing the safety of 5-ASA in LS carriers. Ethics and dissemination The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.

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Contribution to journal
publication status
published
subject
keywords
Clinical Protocols, Clinical trials, Endoscopy, Gastrointestinal tumours, Microbiota
in
BMJ Open
volume
15
issue
11
article number
e100082
publisher
BMJ Publishing Group
external identifiers
  • pmid:41213710
  • scopus:105021459283
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-100082
language
English
LU publication?
yes
id
bb7c3cb3-bd71-4547-a5c7-11f811e6e286
date added to LUP
2025-12-19 14:44:59
date last changed
2025-12-20 03:00:09
@article{bb7c3cb3-bd71-4547-a5c7-11f811e6e286,
  abstract     = {{<p>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 with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (&lt;45 years vs ≥45 years), and assessing the safety of 5-ASA in LS carriers. Ethics and dissemination The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.</p>}},
  author       = {{Backman, Ann Sofie and Frank, Alexander and Lindberg, Lars Joachim and Ljungman, David and Silander, Gustav and Gustafsson, Rita J. and Bozsó, Tünde and Schmidt, Peter T. and Ingre, Michael and Mittlbock, Martina and Löwbeer, Christian and Marsal, Jan and Lindblom, Annika and Tham, Emma and Therkildsen, Christina and Gasche, Christoph}},
  issn         = {{2044-6055}},
  keywords     = {{Clinical Protocols; Clinical trials; Endoscopy; Gastrointestinal tumours; Microbiota}},
  language     = {{eng}},
  number       = {{11}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-100082}},
  doi          = {{10.1136/bmjopen-2025-100082}},
  volume       = {{15}},
  year         = {{2025}},
}