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

Condition studied

patients with head and neck squamous cell carcinoma (HNSCC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in salivary gland function assessed by dynamic Tc99m scintigraphy (excretory fraction), comparing values before and after radiotherapy (biomarker of gland function).

Endpoint detail

Quantitative change in salivary secretion measured by Škach’s test (stimulated and unstimulated) (biomarker of gland function)., Change in ultrasound parameters of salivary glands (gland volume and echostructure) (biomarker of gland structure)., Patient-reported xerostomia assessed by the Xerostomia Questionnaire (XQ)., Quality of life assessed by EORTC QLQ-C30., Safety and tolerability of BoNT/A assessed by: (i) incidence of adverse events related to BoNT/A, (ii) severity of adverse events (CTCAE grading), (iii) occurrence of local complications at the injection site.