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Study on Mesalamine to Prevent Colorectal Cancer in Patients with Lynch Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Lynch syndrome, a genetic condition that increases the risk of developing colorectal cancer. The trial aims to test whether a medication called mesalamine (also known as 5-ASA) can help prevent the development of any colorectal tumors, both non-cancerous and cancerous, in patients with Lynch syndrome. Mesalamine is being compared to a placebo, which is a substance designed to look like the actual medication but does not contain any active ingredients.

Participants in the study will receive either mesalamine or the placebo over a period of 24 months, with an additional follow-up period of 3 months. During this time, regular colonoscopies, which are procedures that allow doctors to look inside the colon, will be conducted to monitor for any signs of tumor development. The goal is to see if mesalamine can reduce the occurrence of colorectal tumors compared to the placebo.

The study will also gather information on the number of tumors per patient, how the tumors progress, and whether the effects of the treatment vary based on factors like a patient's history of colorectal cancer, gender, and age. Safety data will also be collected and compared between the groups receiving mesalamine and the placebo. This research is important for understanding how to better prevent colorectal cancer in individuals with Lynch syndrome.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes confirming that you are a proven tumor-free carrier of a germline pathologic mutation on one of the MMR genes, such as MLH1, MSH2, or MSH6.

    If you are a female of childbearing potential, a pregnancy test will be conducted to ensure a negative result before proceeding.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the active medication, mesalazine, or a placebo. The placebo is designed to look like the active medication but does not contain the active substance.

  4. Step 4

    Medication administration

    If you are assigned to the active medication group, you will receive mesalazine in the form of prolonged-release granules. The dosage is 2 grams, taken orally.

    The medication or placebo will be taken daily for a period of 24 months, with an additional follow-up period of 3 months.

  5. Step 5

    Regular monitoring

    Throughout the trial, regular monitoring will be conducted to assess your health and the occurrence of any colorectal neoplasia, which includes both benign and malignant tumors.

    Monitoring will include colonoscopies and other necessary medical evaluations to track any changes in your condition.

  6. Step 6

    End of treatment

    At the end of the 24-month treatment period, a final assessment will be conducted to evaluate the effects of the medication or placebo on your health.

    This assessment will include a review of any colorectal neoplasia occurrences and other relevant health data.

  7. Step 7

    End of study

    The study concludes after the additional 3-month follow-up period. A final report will be generated to summarize the findings and any implications for colorectal cancer prevention in Lynch syndrome patients.

Who can join the trial?

6 criteria

  • Must have **Lynch syndrome**, which increases the risk of developing colorectal cancer.
  • Must be proven to be tumor-free, including those who have had polyps removed during an endoscopy. An **endoscopy** is a procedure where a doctor uses a special tool to look inside the body.
  • Must have a genetic mutation in one of the **MMR genes**: MLH1, MSH2 (including EpCAM), or MSH6. These are specific genes related to Lynch syndrome.
  • Must be male or female and older than 30 years.
  • Females must either be post-menopausal for more than one year or, if they can have children, must use a highly effective method of birth control. This includes options like birth control pills, hormone implants, or a partner who has been sterilized. They must also have a negative pregnancy test before starting the study.
  • Must sign a written informed consent form before joining the study. This means you agree to participate after being told about the study's details.

Who cannot join the trial?

8 criteria

  • Patients who do not have Lynch syndrome.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to undergo regular colonoscopy procedures. A colonoscopy is a test that allows doctors to look inside your large intestine using a long, flexible tube with a camera.
  • Patients who have a history of allergic reactions to mesalamine (5-ASA) or similar medications. Mesalamine is a drug used to treat inflammation in the intestines.
  • Patients who are currently participating in another clinical trial.
  • Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to give informed consent, which means they cannot understand the study and agree to participate.
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Investigated drugs

Mesalamine is a medication used in this clinical trial to see if it can help prevent colorectal cancer in people with Lynch syndrome. Lynch syndrome is a genetic condition that increases the risk of developing colorectal cancer. Mesalamine works by reducing inflammation in the colon, which might help lower the chance of developing tumors, both benign and malignant. The trial aims to find out if taking mesalamine can reduce the occurrence of these tumors when compared to not taking the medication, as observed through regular colonoscopies over a period of about two years.

What is already known about the treatment

Mesalamine – Mesalamine is administered orally in the form of tablets or capsules. It is currently being studied for its potential to prevent colorectal cancer in individuals with Lynch syndrome, a condition that increases the risk of developing this type of cancer. The main therapeutic indication for mesalamine in this context is to reduce the occurrence of colorectal tumors, both benign and malignant. At the molecular level, mesalamine works by reducing inflammation in the colon, which may help prevent the development of cancerous cells. It is classified pharmacologically as an anti-inflammatory drug, specifically a 5-aminosalicylic acid (5-ASA) compound.

Investigated diseases

Lynch syndrome – Lynch syndrome is a genetic condition that increases the risk of developing colorectal cancer and other types of cancer, often at a younger age. It is caused by inherited mutations in specific genes responsible for repairing DNA. Individuals with Lynch syndrome may develop polyps in the colon, which can progress to cancer if not monitored and managed. The syndrome is characterized by the rapid progression of these polyps to malignancy compared to the general population. It is important for individuals with Lynch syndrome to undergo regular screenings to detect any changes early. The condition is hereditary, meaning it can be passed down from parents to children.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514765-19-01Estimated enrolment150 patientsSponsorKarolinska Institutet

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