drugset / Trial / NCT06530524
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
Phase 2
Not yet recruiting
50 enrolled
Sir Mortimer B. Davis - Jewish General Hospital
Lady Davis Institute · collabMcGill University Health Centre/Research Institute of the McGill University Health Centre · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2026-10-01
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 30 iu | Other |