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Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia
Sponsor: University of California, Davis
Summary
This study evaluates the feasibility and safety of ultrasound-guided intraglandular dexamethasone (corticosteroid) injections into the salivary glands of patients undergoing radiation therapy for head and neck cancer. Primarily, to determine among patients undergoing radiation therapy (RT) as primary with or without chemotherapy for head and neck cancer, the feasibility of intraglandular corticosteroid injections to the salivary glands as measured by missed or delayed days of radiation therapy due to the planned intervention. Secondarily, to determine safety of intraglandular injections to the salivary glands as measured by the incidence of adverse events. Exploratory endpoints will also be tracked to determine, if among the same population, intraglandular corticosteroid injections are efficacious in minimizing the deleterious effects of radiation treatment to the salivary glands as measured by salivary flow rates and patient reported outcomes.
Official title: Intraglandular Salivary Corticosteroid Injections to Prevent Radiation-Induced Xerostomia: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2020-07-02
Completion Date
2022-11-30
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
Dexamethasone 4mg/mL
The 4 mg/mL injection strength may be used for intralesional and soft tissue administration. Doses range from 0.2 mg to 4 mg injected as a single dose at the appropriate site. 1 cc injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites that have been established to produce clinically sufficient distribution of injected solution.
Dexamethasone 10mg/mL
1 cc of 10mg/mL dexamethasone sodium phosphate injection solution injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites per gland.
Locations (1)
University of California, Davis, Department of Otolaryngology
Sacramento, California, United States