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Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
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.
Official title: Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-10-01
Completion Date
2027-12-01
Last Updated
2024-07-31
Healthy Volunteers
No
Interventions
OnabotulinumtoxinA
Injection of onabotulinumtoxinA into the at-risk major salivary glands
Placebo
Injection of normal saline into the at-risk major salivary glands
Locations (1)
McGill University
Montreal, Quebec, Canada