Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia

NCT07802977 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1507683
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerostomia; Head and Neck Squamous Cell Carcinoma

Keywords

Xerostomia; Dexamethasone; Radiation therapy; Salivary gland; Head and neck cancer; Corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Number of Missed or Delayed Days of Radiation Therapy Due to Steroid Injection

  Primary endpoint: Missed or delayed days of RT due to steroid injection. Count of radiation therapy treatment days that were missed or delayed as a direct result of the intraparenchymal dexamethasone injection procedure. To be assessed at every patient encounter.

  From first steroid injection through completion of radiation therapy, up to 6 weeks

Secondary Outcomes (3)

• Number of Participants Experiencing Adverse Events

  From first steroid injection up to 12 weeks (3 months post-treatment)

• Patient Tolerance of Injection Procedure

  At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy

• Ability to Inject 1cc of Dexamethasone Into Multiple Salivary Glands

  At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy

Other Outcomes (5)

• Salivary Flow Rate (Unstimulated and Stimulated)

  Day 0 (baseline, pre-chemo/radiation), Week 3 of RT, Week 6 (completion of RT), Week 12 (6 weeks post-RT), 6 months, and 12 months after first injection

• Score on the Visual Analogue Scale (VAS) Xerostomia Questionnaire

  Screening, Week 3 of RT, Week 6 (completion of RT), 6-12 weeks after RT completion, 6 months, and 12 months after first injection

• Score on the University of Michigan Xerostomia-Related Quality of Life Scale (XeQoLS)

  Screening, Week 3 of RT, Week 6 (completion of RT), 6-12 weeks after RT completion, 6 months, and 12 months after first injection

Study Arms (2)

Dexamethasone 4mg/mL

EXPERIMENTAL

Cohort 1: Ultrasound-guided technique will be used to inject 1 cc of 4mg/mL of dexamethasone into each involved gland (up to 4 total glands) for the first five patients enrolled. Injections are administered at two time points: within 3 days of initiation of radiation therapy and within 1-3 days of starting the 3rd week of radiation therapy. The glands to be included in the injection will be those that are receiving greater than 20 Gy mean dose radiation over the course of the radiotherapy. For patients to be included in this study, they must have at least 2 major salivary glands receiving greater than 20 Gy mean dose.

Drug: Dexamethasone 4mg/mL

Dexamethasone 10mg/mL

EXPERIMENTAL

Cohort 2: The last five patients enrolled will have 1cc of 10mg/mL of dexamethasone injected into each involved gland (up to 4 total glands). Injections are administered at two time points: within 3 days of initiation of radiation therapy and within 1-3 days of starting the 3rd week of radiation therapy. The glands to be included are those receiving greater than 20 Gy mean dose radiation.

Drug: Dexamethasone 10mg/mL

Interventions

Dexamethasone 4mg/mL DRUG

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 4mg/mL

Dexamethasone 10mg/mL DRUG

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.

Dexamethasone 10mg/mL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-80 with recent primary diagnosis of Oropharyngeal, Nasopharyngeal, Hypopharyngeal or Laryngeal Squamous Cell Carcinoma
• Radiation therapy as primary with or without chemotherapy
• Mean dose greater than 20 Gy to 2 or more salivary glands based on dose volume histogram analysis in the radiation treatment planning software

You may not qualify if:

• Patients less than 18 years of age
• Patients greater than 80 years of age
• Patients undergoing any surgical therapies for head and neck cancer
• Tumor involvement of salivary gland
• History of salivary gland removal
• History of prior head and neck radiation therapy
• History of the following xerostomia-inducing autoimmune diseases: Sjogren's, Lupus, IGG4, and Rheumatoid Arthritis
• History of lymphoma
• History of chronic steroid use (greater than 3 months) within the past year
• History of recent steroid use (in the 7 days prior to enrollment in the study)
• History of radioactive iodine
• History of adverse reactions to steroids
• History of recurrent sialadenitis, sialoliths, or sialocele
• History of Mumps
• Chronic adrenal insufficiency

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Department of Otolaryngology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Xerostomia; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Lane Squires, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose-escalation design: The first 5 patients enrolled receive 1 cc of 4mg/mL dexamethasone per gland. Following safety review by the DSMB, the last 5 patients enrolled receive 1 cc of 10mg/mL dexamethasone per gland. Each gland (up to 4) receives injections at two time points during radiation therapy.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 3, 2026
• Study Start: July 2, 2020
• Primary Completion: July 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)