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Study on Semaglutide for Reducing Mucositis in Patients Undergoing High-Dose Chemotherapy with Stem Cell Transplantation

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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 the effects of a medication called semaglutide in patients undergoing high-dose chemotherapy followed by a procedure known as autologous hematopoietic stem cell transplantation (HSCT). The trial aims to see if semaglutide can help reduce the severity of a condition called gastrointestinal mucositis, which is a painful inflammation and ulceration of the digestive tract that can occur as a side effect of chemotherapy. This study is particularly relevant for patients who are receiving treatment for certain types of lymphoma, such as diffuse large B-cell lymphoma and follicular lymphoma.

Participants in the study will receive either semaglutide or a placebo, which is a substance with no active medication. The treatment will be administered as a solution for injection using a pre-filled pen. The study will monitor the participants over a period of time to assess the intensity of gastrointestinal mucositis and other related health factors. The goal is to determine if semaglutide can effectively reduce the discomfort and complications associated with this condition during the chemotherapy and transplantation process.

Throughout the study, researchers will also evaluate other aspects such as changes in inflammation levels and quality of life. The safety of semaglutide will be closely monitored to ensure it is well-tolerated by participants. This trial is an important step in exploring new ways to improve the treatment experience and outcomes for patients undergoing high-dose chemotherapy and stem cell transplantation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the medication semaglutide or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither you nor the researchers will know which treatment you are receiving. This helps ensure the results are unbiased.
Step 2
Medication administration
You will receive the medication or placebo through a subcutaneous injection, which is an injection under the skin. This will be administered using a pre-filled pen.
The dosage will start at 0.25 mg and will be adjusted as the study progresses. The frequency and duration of administration will be explained to you by the study team.
Step 3
Monitoring and assessments
Throughout the study, you will be monitored for any changes in your health. This includes regular assessments of your gastrointestinal health to evaluate the severity of mucositis, which is inflammation of the lining of the digestive system.
You will also be asked to complete questionnaires to assess your quality of life at different points during the study.
Step 4
End of study
The study is expected to continue until June 30, 2025. At the end of the study, the results will be analyzed to determine the effectiveness of semaglutide in reducing the severity of mucositis and improving quality of life.
You will be informed about the findings and any potential implications for your health.

Who can join the trial?

6 criteria

Referral for **auto-HSCT**: This means you have been recommended for a procedure called **autologous hematopoietic stem cell transplantation**, which is a treatment using your own stem cells.
Diagnosis of **relapsed diffuse large B-cell lymphoma (DLBCL)** or **follicular lymphoma**: You have one of these specific types of lymphoma, which is a kind of blood cancer.
Age **18 years or older**: You must be at least 18 years old to participate.
**BMI 18.5 or higher**: Your Body Mass Index, a measure of body fat based on height and weight, must be 18.5 or more.
**ECOG performance status 2 or less**: This is a scale that measures your daily living abilities. A score of 2 or less means you are able to carry out all self-care but are unable to carry out any work activities.
**Literate in Danish and/or English**: You must be able to read and understand either Danish or English.

Who cannot join the trial?

10 criteria

Patients who have any other serious medical conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or similar drugs.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or instructions.
Patients who have a history of certain mental health conditions that could affect their ability to participate.
Patients who have had a recent surgery or medical procedure that could interfere with the study.
Patients who have a history of certain heart conditions or other serious health issues.

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Verified sites

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Rigshospitalet
Copenhagen, Denmark
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Zealand University Hospital
Koege, Denmark

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Investigated drugs

Semaglutide is a medication that is being tested in this clinical trial to see if it can help reduce the side effects of high-dose chemotherapy, specifically focusing on a condition called gastrointestinal mucositis. This condition involves inflammation and soreness in the digestive tract, which can be a painful side effect of chemotherapy. The trial is investigating whether semaglutide can make this side effect less severe for patients who are receiving chemotherapy followed by a procedure called autologous hematopoietic stem cell transplantation. This procedure involves using the patient's own stem cells to help recover from the intense treatment. Semaglutide is being studied to see if it can provide relief and improve the overall treatment experience for these patients.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin and is currently being studied for its potential to reduce the severity of mouth and gut inflammation, a common side effect of high-dose chemotherapy. This medication is being evaluated in clinical trials to see if it can help patients who undergo chemotherapy followed by a type of stem cell transplant. Semaglutide works by mimicking a natural hormone in the body that helps regulate blood sugar levels and has anti-inflammatory effects. It belongs to a class of drugs known as GLP-1 receptor agonists, which are typically used to treat diabetes but are now being explored for other therapeutic uses.

Investigated diseases

Mucositis – Mucositis is an inflammatory condition affecting the mucous membranes lining the digestive tract. It often occurs as a side effect of chemotherapy or radiation therapy. The condition is characterized by redness, swelling, and ulceration, leading to pain and difficulty in eating or swallowing. As the inflammation progresses, it can cause open sores and increase the risk of infection. The severity of mucositis can vary, with symptoms typically appearing a few days after treatment begins and potentially lasting for weeks. It primarily affects the mouth, but can also impact the esophagus and intestines.