drugset / Trial / NCT06530524

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

NCT06530524

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

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 30 iu Other

Indications