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Prevention of radiation-induced salivary gland damage using botulinum toxin type A in patients with head and neck cancer

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What is this trial about?

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

The study involves patients diagnosed with head and neck squamous cell carcinoma who will receive a single injection of botulinum toxin type A into the salivary glands before undergoing radiation treatment. The goal is to see whether this injection can protect the salivary gland from damage that often leads to a dry mouth condition known as xerostomia. The injection is given a short time before the cancer‑directed radiation, and participants will be asked to complete a few simple questionnaires and undergo routine check‑ups during and after the treatment period.

During the study, participants will have a baseline assessment of how well their salivary glands work, using a special imaging test called scintigraphy and a simple saliva‑collection test. After the radiation course, the same tests are repeated to compare any changes. An additional scan using ultrasound will look at the size and texture of the glands, and questionnaires will evaluate any feelings of dry mouth and overall quality of life. Safety will be monitored by recording any side effects or problems at the injection site.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
you agree to take part in the study and sign an informed consent form.
The study staff records basic health information and confirms that head and neck squamous cell carcinoma is the diagnosis.
Step 2
Baseline assessments
Before any treatment, several tests are performed to evaluate salivary gland function:
dynamic tc99m scintigraphy (a scan that measures how well the glands excrete fluid),
škach’s test (measures the amount of saliva produced when stimulated and when at rest),
An ultrasound of the glands to record size and structure,
A questionnaire about dry mouth (xerostomia questionnaire) and a quality‑of‑life survey (eortc qlq‑c30).
Any existing side effects are also documented.
Step 3
Botulinum toxin injection
A single intraglandular injection of botulinum toxin type a (brand name botox) is given.
The product used is boto x 100 jednotek definovaných dle allerganu prášek pro injekční roztok, supplied as a solution for injection.
The dose is 2 ml (millilitres) administered directly into the salivary gland(s).
The injection is performed by a qualified clinician shortly before the start of radiotherapy.
Step 4
Radiotherapy course
After the injection, you receive the planned radiotherapy for head and neck cancer.
The radiotherapy schedule follows the standard protocol prescribed by your oncology team and typically lasts several weeks.
During radiotherapy you continue to be monitored for any adverse events related to the injection.
Step 5
Post‑treatment assessments and safety monitoring
Once radiotherapy is completed, the same set of tests performed at baseline is repeated:
Dynamic tc99m scintigraphy, škach’s test, ultrasound of the salivary glands, xerostomia questionnaire, and quality‑of‑life survey.
The results are compared with the baseline values to determine any change in salivary gland function.
All side effects or complications at the injection site are recorded and graded according to standard criteria.
Step 6
Study completion
After the final assessments, the study data are analyzed.
You are thanked for participation and any remaining questions are addressed by the study team.

Who can join the trial?

4 criteria

You must be at least 18 years old.
You must have a diagnosis of head and neck squamous cell carcinoma that has been confirmed by a tissue test (a lab examination of a small sample), and your doctor must plan to treat you with radiotherapy (using high‑energy rays to target the cancer).
Your two submandibular glands (the saliva‑producing glands under your jaw) must work equally well when checked with a special scan called Tc99m scintigraphy before treatment.
You need to sign a written informed consent form, showing that you understand the study and agree to take part.

Who cannot join the trial?

5 criteria

Previous radiation treatment to the head and neck – you cannot join if you have already received radiotherapy (radiation therapy) in that area.
Any known salivary gland problems, such as sialolithiasis (salivary stones) or repeated sialadenitis (inflammation of the salivary glands).
Pregnancy or breastfeeding – women who are pregnant or nursing cannot take part.
Allergy to botulinum toxin or having a disorder that affects how nerves talk to muscles (neuromuscular transmission disorders).
Previous surgery that involved the major salivary glands – if you have had such an operation, you will be considered individually and may be excluded.

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Fakultni Nemocnice Kralovske Vinohrady
Responsive
Prague, Czechia

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Investigated drugs

Botox is a medication made from a purified form of botulinum toxin type A. In this study, it is given as an injection directly into the salivary glands before the patient starts radiotherapy for head and neck cancer. The purpose of the injection is to see if it can protect the glands from the damage that radiation can cause, helping to keep saliva production normal during and after treatment.

Botulinum Toxin Type A

What is already known about the treatment

Botox - Botox is supplied as a sterile solution for injection that is given directly into the salivary glands before radiation treatment. It is an approved drug widely used to treat muscle spasms and cosmetic wrinkles, and extensive research documents its safety and action. The toxin works by blocking a nerve signal that tells the gland to release fluid, which temporarily reduces saliva production. It belongs to the class of neuromuscular blocking agents, specifically botulinum toxin type A.

Investigated diseases

Head and neck squamous cell carcinoma - Head and neck squamous cell carcinoma is a cancer that starts in the flat cells lining the mouth, throat, voice box, and nearby areas. It usually begins as a small, painless lump or ulcer that may grow slowly at first. Over time the tumor can become larger and spread to nearby tissues such as the tongue, floor of mouth, or larynx. It may also extend into regional lymph nodes, causing swelling in the neck. As it advances, the cancer can involve more of the surrounding structures, leading to increased difficulty in swallowing, speaking, or breathing.