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Comparison of esketamine hydrochloride mouthwash and intravenous esketamine to reduce pain from oral mucositis in patients undergoing hematopoietic stem cell transplantation

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study aims to compare the effectiveness of two ways of giving a medication to manage pain caused by Oral mucositis. This condition involves painful inflammation and sores in the mouth and throat, which often occurs as a side effect of treatments like chemotherapy or radiotherapy. The study focuses on patients undergoing a hematopoietic stem cell transplantation, a procedure used to replace damaged bone marrow with healthy stem cells.

One group will receive esketamine hydrochloride in the form of a mouthwash, which is swallowed or used to rinse the mouth. The other group will receive esketamine through an intravenous infusion, which means the medicine is delivered directly into a vein. By comparing these two methods, researchers want to see if the mouthwash can provide similar pain relief to the liquid delivered through a vein.

During the study, participants will have their pain levels monitored to see how well each method works. Information will also be collected regarding side effects, the ability to eat or drink, and the amount of other pain medications needed during the treatment period. The researchers will also check the levels of the medication in the blood to understand how the body processes it through different methods.

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
Study entry and treatment assignment
Upon joining the study, an assignment is made to one of two treatment groups to address oral mucositis, which is inflammation and sores in the mouth and throat.
One group receives an esketamine mouthwash, while the other group receives esketamine through an intravenous infusion, which means the medicine is delivered directly into a vein.
Step 2
Administration of medication
If assigned to the mouthwash group, an esketamine hydrochloride mouthwash at a dose of 80 mg is used orally.
If assigned to the infusion group, esketamine is administered through an intravenous infusion at a dose of 0.3 mg/kg/h (milligrams per kilogram of body weight per hour).
Step 3
Daily monitoring and assessments
Pain levels in the mouth and throat are measured using a numerical rating scale, which is a system to rate the intensity of pain.
A daily oral mucositis questionnaire is completed to track the condition of the mouth.
Daily reports are made regarding the frequency, severity, and type of any side effects felt in the body or locally in the mouth.
Information is collected daily regarding oral intake, including the use of tube feeding or parenteral nutrition (liquid nutrition delivered through a vein).
Step 4
Clinical tracking and study conclusion
Medical staff monitor the total amount of morphine-equivalent doses used for pain relief during the treatment period.
The total number of hospital days and the total number of treatment days are recorded.
Blood samples are taken at specific times to check plasma concentrations, which refers to the amount of medicine present in the bloodstream.

Who can join the trial?

6 criteria

You must be 18 years of age or older.
You must be receiving high-dose chemotherapy, which is a strong type of medicine used to kill cancer cells, to prepare for a stem cell transplant (a procedure where healthy stem cells are put into the body to replace damaged ones).
You must develop oral mucositis, which is painful sores or inflammation inside the mouth or throat, that is severe enough to be rated as grade 2 or higher by medical experts.
The pain from the mouth or throat sores must not be relieved by the standard painkillers you are currently taking.
You must be able to provide written consent, which means signing a formal document agreeing to take part in the study.
You must be able to speak and understand Dutch or English well enough to participate in the study and fill out medical forms.

Who cannot join the trial?

12 criteria

You have an allergy, which is an immune system reaction, to esketamine or medicines similar to it.
You are currently taking part in another medical study that could affect the results of this one.
You are unable to communicate effectively because you do not speak enough Dutch or English.
Your doctor decides that participating in this study is unsafe or not suitable for your health.
You have used esketamine within the last 30 days.
You have experienced psychosis, which is a mental state where a person loses touch with reality, or a severe psychiatric illness that is not being treated.
You have a history of drug abuse or misuse of ketamine.
You have serious liver problems or a heart condition that is not stable.
You have increased intracranial pressure, which means there is too much pressure inside your skull.
You have an infection in your mouth or throat that has not been treated.
You are unable to use mouthwash safely, for example, because you have swallowing problems or struggle with drowsiness, which is feeling very sleepy.
You are pregnant or currently breastfeeding.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Esketamine
mouthwash is a liquid medicine used to rinse the mouth. In this study, it is being tested to see if it can help reduce pain caused by inflammation and sores in the mouth that occur during chemotherapy or radiation therapy.
Esketamine
is a medicine given through a needle directly into a vein. It is being used in this trial to compare its effectiveness in reducing mouth pain against the mouthwash version.

What is already known about the treatment

Esketamine hydrochloride
This medication is administered as a mouthwash that is applied directly to the mouth. While it is currently used in medical practice for anesthesia and pain relief, this specific oral form is being studied for its ability to treat mouth sores caused by cancer treatments. It works by blocking certain chemical messengers in the brain that send pain signals throughout the body. This substance belongs to a group of drugs known as NMDA receptor antagonists.
Esketamine
This medication is given through an intravenous infusion, which means it is delivered directly into a vein. It is an established medical treatment used to manage pain and provide sedation during various procedures. On a molecular level, it works by interfering with specific receptors in the nervous system to prevent pain messages from being processed. This drug is classified as an NMDA receptor antagonist.

Investigated diseases

Oral mucositis - This condition involves the inflammation and ulceration of the mucous membranes lining the mouth and throat. It often develops as a side effect of intensive medical treatments like chemotherapy or radiation. The process typically begins with redness and swelling of the oral tissues. As it progresses, painful sores or ulcers may form on the gums, tongue, or inner cheeks. These sores can make eating and swallowing difficult.