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NOT YET RECRUITING
NCT06530524
PHASE2

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-10-01

Completion Date

2027-12-01

Last Updated

2024-07-31

Healthy Volunteers

No

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

Locations (1)

McGill University

Montreal, Quebec, Canada