About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).
Disqualifiers
Previous radiation to the head and neck
Previous treatment for head and neck cancer
Personal history of xerostomia
Hypersensitivity to onabotulinumtoxinA
Trial design
Parallel
Treatments tested in this trial
OnabotulinumtoxinA
DrugInjection of onabotulinumtoxinA into the at-risk major salivary glands
Placebo
DrugInjection of normal saline into the at-risk major salivary glands
Treatment groups
Trial outcomes
Primary outcomes
Xerostomia-related quality of life
University of Washington Quality of Life questionnaire (higher score is better)
Secondary outcomes
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
Sponsors and contacts
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Sir Mortimer B. Davis - Jewish General Hospital
Lead sponsor
Lady Davis Institute
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
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