Ongoing Clinical Trials for Mucosal Inflammation
There is currently 1 ongoing clinical trial investigating new treatments for mucosal inflammation. This trial is exploring whether semaglutide can help reduce the severity of gastrointestinal mucositis, a painful inflammation of the digestive tract that occurs as a side effect of high-dose chemotherapy in patients undergoing stem cell transplantation.
Clinical trial locations
Study on Semaglutide for Reducing Mucositis in Patients Undergoing High-Dose Chemotherapy with Stem Cell Transplantation
This clinical trial is investigating whether semaglutide can help reduce the severity of gastrointestinal mucositis in patients receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The study specifically targets patients with certain types of lymphoma, such as diffuse large B-cell lymphoma and follicular lymphoma.
Main inclusion criteria:
- Patients who have been referred for autologous hematopoietic stem cell transplantation, a treatment using their own stem cells
- Diagnosis of relapsed diffuse large B-cell lymphoma or follicular lymphoma
- Age 18 years or older
- Body Mass Index of 18.5 or higher
- ECOG performance status of 2 or less, meaning patients can carry out self-care but may be unable to work
- Ability to read and understand Danish and/or English
Main exclusion criteria:
- Other serious medical conditions that could interfere with the study
- Current participation in another clinical trial
- Recent infection or illness that could affect study results
- Pregnancy or breastfeeding
- Known allergy to the study medication or similar drugs
- History of drug or alcohol abuse
- Inability to follow study procedures or instructions
- History of certain mental health conditions that could affect participation
- Recent surgery or medical procedure that could interfere with the study
- History of certain heart conditions or other serious health issues
Focus and goal:
The study aims to determine if semaglutide can effectively reduce the discomfort and complications associated with gastrointestinal mucositis during chemotherapy and stem cell transplantation. Participants will be randomly assigned to receive either semaglutide or a placebo through subcutaneous injections using a pre-filled pen. The trial is double-blind, meaning neither participants nor researchers will know who is receiving the active medication. Throughout the study, researchers will monitor the intensity of gastrointestinal mucositis, changes in inflammation levels, and quality of life. The study is expected to continue until June 30, 2025.
Investigational drug:
Semaglutide is the medication being tested in this trial. It is administered as an injection under the skin and belongs to a class of drugs known as GLP-1 receptor agonists, typically used to treat diabetes. The medication works by mimicking a natural hormone in the body that helps regulate blood sugar levels and has anti-inflammatory effects. In this trial, researchers are exploring whether these anti-inflammatory properties can help reduce the severity of mouth and gut inflammation caused by high-dose chemotherapy. The dosage will start at 0.25 mg and will be adjusted as the study progresses.
Summary
Currently, there is one clinical trial investigating treatments for mucosal inflammation related to chemotherapy. This trial is being conducted in Denmark and focuses specifically on patients undergoing autologous stem cell transplantation for lymphoma. The study represents an important step in exploring whether semaglutide, a medication with anti-inflammatory properties, can improve the treatment experience and outcomes for patients suffering from chemotherapy-induced gastrointestinal mucositis. The trial’s double-blind design and comprehensive monitoring approach aim to provide reliable evidence about the potential benefits of this therapeutic approach.