AuthorisedTherapeutic exploratory (Phase II)Interventional

Comparison of esketamine mouthwash versus intravenous administration for the treatment of chemotherapy/radiotherapy-induced mucositis

This study is looking at new ways to treat painful mouth sores, called oral mucositis, which can happen after chemotherapy or radiotherapy for cancer. We are comparing two ways of giving the drug esketamine: as a mouthwash or as a drip into a vein (intravenous, or IV). The main goal is to find out if the esketamine mouthwash is just as good as the IV drip at reducing pain in the mouth and throat after the first dose. We also want to check for any side effects and how they affect daily activities like eating. This is a Phase II study, which means we are exploring if the treatment is safe and effective in people, hoping to make treatment easier for patients in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

13 Mar 2026

Oral mucositis

What is this study about?

This research is specifically designed for people who develop painful mouth and throat sores, known as oral mucositis. These sores are a common and difficult side effect of cancer treatments like chemotherapy and radiotherapy. They can make it very hard to eat, drink, and even talk, significantly impacting a person's quality of life during an already challenging time.

The study is comparing two ways of giving a medicine called esketamine. One way is as a mouthwash, which might be simpler and more comfortable for patients. The other is as a drip directly into a vein, which is a more traditional way to give certain medications. The main purpose is to see if the esketamine mouthwash can relieve pain just as effectively as the IV drip. If it does, it could offer a much-needed, easier alternative for managing this very uncomfortable side effect.

Researchers will also be closely monitoring any side effects, how the treatment affects eating habits, and overall comfort levels. By doing this, they hope to gather enough information to understand how well the mouthwash works, how safe it is, and ultimately, improve care for people undergoing cancer treatment.

Key takeaways

This study evaluates esketamine mouthwash against an IV drip for painful mouth sores.
It aims to see if the mouthwash is as effective for pain relief.
Participants must be adults with mouth sores from cancer treatment.
Risks and benefits will be discussed; you can withdraw anytime.
The goal is to find easier ways to manage treatment side effects.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

The most important requirement is that you are suffering from oral mucositis, which are painful sores in your mouth and throat. These sores must be a result of the chemotherapy or radiotherapy you are receiving for cancer.

Your healthcare team will thoroughly review your medical history and current health to make sure this study is suitable and safe for you. They will explain all the criteria in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have painful mouth and throat sores (oral mucositis)?
Are these sores caused by your chemotherapy or radiotherapy?
Are you able to follow the study instructions and attend appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. Once enrolled, you would receive either the esketamine mouthwash or the esketamine through an IV drip. The first pain assessment would be done about an hour after your first dose. You would be asked to regularly rate your pain, possibly using a simple scale, and report any side effects you experience. Your eating habits and overall comfort would also be monitored daily through questionnaires. There will be an assessment of how much medicine you are able to take, and your progress will be tracked until the end of your treatment period. Blood samples might be taken at certain times to check the level of the drug in your system. The total duration of your participation would depend on your course of cancer treatment and when the study assessments end.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to relieve the pain from your mouth sores, possibly with a new and easier-to-use mouthwash. However, as with any medication, there's always a chance of side effects, which the study team will closely monitor and discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What are oral mucositis sores?

These are painful sores that can develop in your mouth and throat as a side effect of certain cancer treatments like chemotherapy and radiotherapy.

What is esketamine?

Esketamine is a medicine that is being studied to see if it can help reduce the pain from these mouth sores. It's being tested in two forms: a mouthwash and a drip.

Will I definitely get the mouthwash?

No, participants will be randomly assigned to receive either the esketamine mouthwash or the esketamine through an IV drip. You won't get to choose which one you receive.

How long will I be in the study?

The length of your participation will depend on your cancer treatment schedule and how long the study needs to monitor your progress and assessments.

What does a 'Phase II' study mean?

Phase II studies are usually smaller trials focused on finding out if a new treatment is safe and effective in people, and if it has potential for future larger studies.