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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Adjkiounu Uvr Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.01.2026

Trial locations

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.

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.

Trial ID:
2025-522545-22-00
Protocol code:
2025-005
Trial Phase:
Therapeutic exploratory (Phase II)

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