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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
50
Injection of onabotulinumtoxinA into the at-risk major salivary glands
Injection of normal saline into the at-risk major salivary glands
McGill University
Montreal, Quebec, Canada
Xerostomia-related quality of life
University of Washington Quality of Life questionnaire (higher score is better)
Time frame: Pretreatment, 6 and 12 months from treatment completion
Unstimulated salivary function using salivary gland scintigraphy
Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy
Time frame: Pretreatment and 12 months from treatment completion
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