NCT06530524

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head Neck Cancer
• Xerostomia Following Radiotherapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study