Clinical trial · Interventional
Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia
Intraglandular Salivary Corticosteroid Injections to Prevent Radiation-Induced Xerostomia: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone 10mg/mL | Drug | Dexamethasone | ALIAS |
| Dexamethasone 4mg/mL | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexamethasone 4mg/mL
- description
- 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.
- interventionNames
- Drug: Dexamethasone 4mg/mL
- type
- EXPERIMENTAL
- label
- Dexamethasone 10mg/mL
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Malignant tumor or enlarged lymph nodes interfering with pathway for ultrasound-guided injections * Vulnerable populations: prisoners, adult patients unable to consent, pregnant women
References
Publications (0)
Data not yet available