AuthorisedTherapeutic exploratory (Phase II)Interventional

Prevention of radiation-induced salivary gland damage by botulinum toxin application in patients with head and neck cancers

This study aims to see if an injection of botulinum toxin (Botox) can protect the glands in your mouth that produce spit, called salivary glands, during radiation treatment for head and neck cancer. Radiation therapy can sometimes damage these glands, leading to a very dry mouth, which can be uncomfortable and affect your day-to-day life. Researchers want to find out if Botox can reduce this damage. They will compare how well your glands are working before and after radiation, look at how much spit you produce, and ask about your experience with dry mouth to see if this treatment is helpful and safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fakultni Nemocnice Kralovske Vinohrady

Enrolment target

Start

02 Jun 2026

patients with head and neck squamous cell carcinoma (HNSCC)

What is this study about?

When people have radiation therapy for head and neck cancers, a common problem that can come up afterwards is a very dry mouth. This happens because the radiation can unfortunately damage the glands that make spit, which are called salivary glands. Having a dry mouth all the time, also known as xerostomia, can be uncomfortable and make it harder to eat, speak, and even sleep comfortably.

This study is trying to find a way to protect these important glands during radiation treatment. Researchers are looking at whether a medicine called botulinum toxin, more commonly known as Botox, can help. Botox is a well-known medication, often used for other medical purposes, and in this study, it's being tested to see if it can shield your salivary glands from the effects of radiation.

The main goal is to see if giving patients Botox injections before their radiation treatment can keep their salivary glands working better. They'll be checking how well the glands are producing spit both before and after radiotherapy, and also asking patients how much a dry mouth affects them. This research is important because if it works, it could significantly improve the quality of life for many people undergoing treatment for head and neck cancer by reducing uncomfortable side effects.

Key takeaways

Exploring if Botox protects spit glands during cancer radiation.
Aims to reduce dry mouth (xerostomia) after head and neck cancer treatment.
Involves Botox injections before radiation.
Will assess gland function, spit production, and patient comfort.
Phase II study, focusing on safety and promising results for future research.

Who may be eligible?

This study is designed for adults who have been diagnosed with head and neck cancer. You need to be at least 18 years old to take part, and there's no upper age limit.

Both men and women are welcome to participate. The study is specifically for patients whose cancer is a type called squamous cell carcinoma, located in the head and neck area.

The research team will have specific medical checks to make sure this study is right and safe for you. They will look at your overall health and your specific cancer diagnosis to confirm you meet all the necessary requirements.

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?
Have you been diagnosed with head and neck squamous cell carcinoma (a type of head and neck cancer)?
Are you about to start radiation treatment for your cancer?
Are you able to participate in regular check-ups and medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive an injection of Botox. This would happen before you start your radiation treatment. The study team will check your salivary glands regularly, both before and after your radiation therapy. These checks might include special scans to see how well your glands are working, tests to measure how much spit you produce, and ultrasound scans to look at the structure of your glands.

You will also be asked to complete questionnaires about your experience with a dry mouth and your general quality of life. This helps the researchers understand how the treatment is affecting you. The team will also monitor you closely for any side effects or reactions to the Botox injection. The total duration of your involvement will depend on the follow-up schedule designed to capture full effects and safety information.

Potential risks and benefits

Taking part in this study may offer a potential benefit of protecting your salivary glands and reducing the chance of a dry mouth after radiation therapy. However, there's no guarantee the treatment will work for everyone, and it's also possible that you may experience side effects from the Botox injection, although these are typically mild and temporary. The research team will carefully monitor you for any issues. 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
Czechia

Common questions

What is head and neck cancer?

Head and neck cancer refers to cancers that start in the head or neck area, such as in the mouth, throat, voice box, or salivary glands. The study focuses on a common type called squamous cell carcinoma.

What does radiation therapy do?

Radiation therapy is a common cancer treatment that uses high-energy rays to kill cancer cells. While effective, it can sometimes affect healthy tissues nearby, like the spit-producing glands.

What is Botox, and is it safe?

Botox (botulinum toxin) is a medicine often used in small doses for certain medical conditions. The study will carefully monitor its safety when used to protect salivary glands, looking out for any side effects.

What is a 'dry mouth' and why does it matter?

A 'dry mouth' (xerostomia) means your mouth doesn't produce enough spit. This can make eating, speaking, and swallowing difficult, and can increase the risk of dental problems.

Will I know if I'm getting the Botox or a dummy treatment?

The study design isn't specified as a 'blinded' study, so you may be aware if you are receiving the active treatment. The research team will explain this clearly before you decide to join.