XerostomiaPhase 1NCT07802977
Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia
A Phase 1 study testing Dexamethasone 4mg/mL and Dexamethasone 10mg/mL in people with Xerostomia and Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Xerostomia, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Dexamethasone 4mg/mL and Dexamethasone 10mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2020to 30 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Department of Otolaryngology
Sacramento, California, 95817
About this study
Official title: Intraglandular Salivary Corticosteroid Injections to Prevent Radiation-Induced Xerostomia: A Pilot Study
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.
Read the detailed description
This project will be divided into multiple phases - for this first phase, investigators plan to assess the safety and feasibility of the planned intervention. Using the introductory and background principles established above, investigators have planned the following intervention based off of available published data: serial intraglandular dexamethasone injections to salivary gland(s) affected by planned radiation treatment for non-salivary head and neck cancer. Ultrasound-guided technique will then 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. 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 ultimate aim of this study is to provide enrolled patients prolonged avoidance of radiation-induced salivary damage by minimizing the inflammatory-mediated destruction of salivary gland tissue, as well as decreasing the incidence of post-treatment xerostomia and its deleterious effect on oral and dental hygiene, nutrition, voice, and overall quality of life.
- Conditions
- Xerostomia, Head and Neck Squamous Cell Carcinoma
- Being tested
- Dexamethasone 4mg/mL, Dexamethasone 10mg/mL
- Keywords
- Xerostomia, Dexamethasone, Radiation therapy, Salivary gland, Head and neck cancer, Corticosteroid injection
- Medical subject headings
- Xerostomia, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mg/mLDrug
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/mLDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone 10mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first steroid injection through completion of radiation therapy, up to 6 weeks
Secondary outcomes (3)
Number of Participants Experiencing Adverse Events
Safety and feasibility at 3 months following investigational treatment. To be assessed at every patient encounter. Incidence of adverse events including, but not limited to: injection-site pain reported longer than 24 hours post-procedure, seroma, hematoma, missed injections, sialadenitis.
Measured: From first steroid injection up to 12 weeks (3 months post-treatment)
Patient Tolerance of Injection Procedure
Assessment of patient tolerance during and after each ultrasound-guided intraparenchymal dexamethasone injection procedure.
Measured: 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
Feasibility assessment of the ability to successfully inject 1cc of dexamethasone solution into multiple salivary glands (up to 4) as planned per protocol.
Measured: At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start2 Jul 2020
- Primary completion30 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lane Squires, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802977
- Sponsor's protocol ID
- 1507683
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraglandular Salivary Corticosteroid Injections to Prevent Radiation-Induced Xerostomia: A Pilot Study
- ClinicalTrials.gov ID
- NCT07802977
- Acronym / sponsor ID
- 1507683
- Conditions
- Xerostomia, Head and Neck Squamous Cell Carcinoma
- Keywords
- Xerostomia, Dexamethasone, Radiation therapy, Salivary gland, Head and neck cancer, Corticosteroid injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will be divided into multiple phases - for this first phase, investigators plan to assess the safety and feasibility of the planned intervention. Using the introductory and background principles established above, investigators have planned the following intervention based off of available published data: serial intraglandular dexamethasone injections to salivary gland(s) affected by planned radiation treatment for non-salivary head and neck cancer. Ultrasound-guided technique will then 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. 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 ultimate aim of this study is to provide enrolled patients prolonged avoidance of radiation-induced salivary damage by minimizing the inflammatory-mediated destruction of salivary gland tissue, as well as decreasing the incidence of post-treatment xerostomia and its deleterious effect on oral and dental hygiene, nutrition, voice, and overall quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 4mg/mL | Experimental | Drug: Dexamethasone 4mg/mLCohort 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. |
| Dexamethasone 10mg/mL | Experimental | Drug: Dexamethasone 10mg/mLCohort 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 4mg/mLThe 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. | Drug | Dexamethasone 4mg/mL |
| Dexamethasone 10mg/mL1 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. | Drug | Dexamethasone 10mg/mL |
Primary outcome
Number of Missed or Delayed Days of Radiation Therapy Due to Steroid Injection
Time frame: From first steroid injection through completion of radiation therapy, up to 6 weeks
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.
3 secondary outcomes
Number of Participants Experiencing Adverse Events
Time frame: From first steroid injection up to 12 weeks (3 months post-treatment)
Patient Tolerance of Injection Procedure
Time frame: 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
Time frame: At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lane Squires, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone 4mg/mL and Dexamethasone 10mg/mL in people with Xerostomia and Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Missed or Delayed Days of Radiation Therapy Due to Steroid Injection (time frame: From first steroid injection through completion of radiation therapy, up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.