Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OnabotulinumtoxinA, Placebo.
- Who it may be relevant to
- Registry conditions: Head Neck Cancer, Xerostomia Following Radiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
Overview
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.
Interventions
- Drug OnabotulinumtoxinA
Injection of onabotulinumtoxinA into the at-risk major salivary glands - Drug Placebo
Injection of normal saline into the at-risk major salivary glands
Primary outcome measures
- Xerostomia-related quality of life [Time frame: Pretreatment, 6 and 12 months from treatment completion]
Secondary outcome measures (1)
- Unstimulated salivary function using salivary gland scintigraphy [Time frame: Pretreatment and 12 months from treatment completion]
Eligibility criteria
Inclusion criteria
- Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).
Exclusion criteria
- Previous radiation to the head and neck
- Previous treatment for head and neck cancer
- Personal history of xerostomia
- Hypersensitivity to onabotulinumtoxinA
- Previous major salivary gland surgery
- Previous exposure to radioactive iodine therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- McGill University — Montreal
Identifiers
NCT: NCT06530524 · PROTOX