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2025-524720-22-00Not yet recruitingPhase 2

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Jun 2026

Next steps

Brief summary (registry, in English)

To evaluate whether intraglandular application of botulinum toxin type A prior to radiotherapy preserves salivary gland function.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
31 Mar 2026
Start date
1 May 2026
Lead sponsor
Fakultni Nemocnice Kralovske Vinohrady
EU CT number
2025-524720-22-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with head and neck squamous cell carcinoma who will have radiotherapy. It tests botulinum toxin type A injected into the salivary glands before radiotherapy to protect salivary gland function.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Head and neck squamous cell carcinoma confirmed by tissue examination, with radiotherapy planned.
Earlier treatment
No earlier radiotherapy to the head and neck region.
Biomarker or test result
The submandibular salivary glands must work symmetrically on the Tc99m scintigraphy scan done before treatment.

Main reasons for not taking part

  • Earlier radiotherapy to the head and neck region
  • Known salivary gland disease, such as salivary stones or repeated gland inflammation
  • Pregnancy or breastfeeding
  • Known allergy to botulinum toxin or a nerve-muscle transmission disorder
  • Earlier surgery affecting the major salivary glands (assessed case by case)

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiotherapy to the head and neck region
  • Prior surgery affecting major salivary glands (to be evaluated individually)

Other illness

  • Known salivary gland disease (e.g., sialolithiasis, recurrent sialadenitis)
  • Known allergy to botulinum toxin or neuromuscular transmission disorders

Other

  • Pregnancy or lactation

Who the study is looking for

  • Age ≥ 18 years
  • Histologically confirmed head and neck squamous cell carcinoma indicated for radiotherapy
  • Symmetrical function of submandibular glands on pre-treatment Tc99m scintigraphy
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fakultni nemocnice Kralovske VinohradyPragueCzechiaNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.