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Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 31, 2024 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06530524
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Collaborators: Lady Davis Institute, McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Head Neck Cancer, Xerostomia Following Radiotherapy
Related terms Head and Neck Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov