The value of intraglandular application of botulinum toxin for prevention of radiation-induced sialadenitis in head and neck cancer: a scintigraphic analysis.

The value of intraglandular application of botulinum toxin for prevention of radiation-induced sialadenitis in head and neck cancer: a scintigraphic analysis. - BoNTA/B

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004595

Enrollment

Registered

2012-12-14

Start date

2010-07-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15.9 C33

Interventions

Group 1: Direct application of BoNT/A (15U) into Gl.submand. right, and NaCl to the Gl. submand. left. Sinlge Application before radio therapy. Group 2: Direct application of BoNT/A (15U) into Gl.subm

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a squamous cell carcinoma of the upper airways and oesophagus Signed informed consent form Cognitive and physical ability, to understand the aim of the trial and to adhere to the protocol Age = 40 years Gender: female and male participants fertile woman over 40 years have to use one of the following contaceptive methods: the pill and contraceptive coil, since at least to one month before study start barrier with spermicide (condom or diaphragm), tube ligature. Fertile woman are defined as women whose last menstruation dates back no longer than one year No functional restrictions and sides differences detected by scintigraphy of the salivary glands

Exclusion criteria

Exclusion criteria: condition after exstirpation of the salivary glands known illnesses of the salivary glands Concomitant medication, which affect the salivary glands condition after previous radiotherapy of cervical soft tissue pregnancy, lactation, Irenat-Therapy, hypersensitivity to Botulinum toxin or one of the other components

Design outcomes

Primary

Measure	Time frame
Difference of the proportional uptake of radionuklide after treatment with BoNT or placebo. The primary endpoint will be determined via szinitgraphiy before and after study treatment.	—

Secondary

Measure	Time frame
difference of the ejection fractions of the salviary glands either treated withe BoNT or placebo after administration of an irritant drink	—

Countries

Germany

Contacts

Public ContactAfshin Teymoortash

Klinik für Hals-, Nasen- und Ohrenheilkunde der Philipps-Universität Universitätsklinikum Giessen und Marburg, Standort Marburg

teymoort@med.uni-marburg.de06421 58-66808

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026