patients with head and neck squamous cell carcinoma (HNSCC)
Conditions
Brief summary
Change in salivary gland function assessed by dynamic Tc99m scintigraphy (excretory fraction), comparing values before and after radiotherapy (biomarker of gland function).
Detailed description
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.
Interventions
DRUGBOTOX 100 jednotek definovaných dle Allerganu prášek pro injekční roztok
Sponsors
Fakultni Nemocnice Kralovske Vinohrady
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in salivary gland function assessed by dynamic Tc99m scintigraphy (excretory fraction), comparing values before and after radiotherapy (biomarker of gland function). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed