A Phase 1 interventional study of Dexamethasone 4mg/mL and Dexamethasone 10mg/mL in Xerostomia and Head and Neck Squamous Cell Carcinoma, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of California, Davis · Phase 1, Interventional, and Prevention
Among 88 studies in Xerostomia with a site in United States — 8 open to participants now, 14 under way, 2 of them phase 3. Xerostomia · United States.
Among the 88 studies in Xerostomia with a site in United States, this one is the 67th largest by enrollment of the 73 interventional ones that give a count, is one of 5 that started in 2020, is one of 13 in phase 1, and was the 88th registered.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
Browse Xerostomia studies →8 of the 88 studies in Xerostomia with a site in United States are open now. Recruiting first, the newest first:
National Institute of Dental and Craniofacial Research (NIDCR) · Sites in United States
Ages 18–75
RiboX Therapeutics Ltd. · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18–90
Case Western Reserve University · Sites in United States
Ages 55+ · Healthy volunteers
University of Rochester · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 26 Xerostomia studies recruiting now, 15 (58%) set no upper age limit and 7 (27%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 22 · Phase 3 3 · Phase 4 1
First in 1979; this study’s year is marked. 5 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 44 across 235 interventional studies indexed under Xerostomia.
Median enrollment 30 across the 73 interventional studies, 100 across the 15 observational. Of the 69 that completed or were terminated, 30 (43%) have results posted.
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26 of 88 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 1 study filed under Xerostomia — fewer than ten, so there is no comparison to draw.
6 of the studies in Xerostomia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT07771907Access Business GroupNew Functional Ingredient for Oral Care | 2026-12 |
| NCT05060341MeiraGTx, LLCLong-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia | 2027-03 |
| NCT06928142Otsuka Pharmaceutical Development & Commercialization, Inc.A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's | 2027-03-13 |
| NCT06714253RiboX Therapeutics Ltd.Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1 | 2027-08 |
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Among the 88 studies in Xerostomia with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug page: Dexamethasone
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.
Drug page: Dexamethasone
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.
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.
Time frame: From first steroid injection through completion of radiation therapy, up to 6 weeks
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.
Time frame: 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.
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
Feasibility assessment of the ability to successfully inject 1cc of dexamethasone solution into multiple salivary glands (up to 4) as planned per protocol.
Time frame: At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy
Salivary Flow Rate (Unstimulated and Stimulated)
Baseline salivary flow rate measured in g/minute. Salivary gland hypofunction is defined as whole unstimulated saliva less than 0.1 g/minute or whole chewing stimulated saliva 0.7 g/minute or less, or both. Higher flow rates indicate better salivary function (better outcome).
Time frame: 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
The enrolled subjects will be provided this questionnaire after enrollment and consent completed. This questionnaire involves marking a specific point on a 100-mm horizontal scale to evaluate the level of xerostomia the patient may be experiencing at the specified points during the study. The VAS Xerostomia Questionnaire includes 8 items assessing difficulty speaking and swallowing due to dryness, saliva amount, dryness of mouth, throat, lips, tongue, and level of thirst. Scores range from 0 mm to 100 mm per item, where higher scores indicate greater xerostomia severity (worse outcome).
Time frame: 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)
All subjects will complete a 15-item xerostomia-related quality of life scale (XeQoLS). Patients will answer the questions by checking the box that describes best how true each statement has been for the patient during the past 7 days. Higher scores represent greater degree of symptoms. The scale uses a 5-point Likert scale (0 = "Not at all," 1 = "A little," 2 = "Somewhat," 3 = "Quite a bit," 4 = "Very much") across four domains: physical functioning (items 1, 6, 10, 12), pain/discomfort (items 2, 3, 7, 9), personal/psychological functioning (items 8, 13, 14, 15), and social functioning (items 4, 5, 11). Higher scores indicate worse xerostomia-related quality of life (worse outcome).
Time frame: Screening, Week 3 of RT, Week 6 (completion of RT), 6-12 weeks after RT completion, 6 months, and 12 months after first injection
Change in Salivary Gland Volume on CT/PET Imaging
Baseline assessed with initial CT neck obtained for evaluation of patient's disease status. This will not be an additional scan for the patient as this is needed for the cancer diagnosis and RT planning. The follow up glandular volume will be measured with routine post-RT PET scan imaging and also will not be an additional scan.
Time frame: Baseline (pre-treatment) and 12-18 weeks post-treatment
Incidence of Sialadenitis
Incidence of sialadenitis as demonstrated clinically during the follow up visits. This will be assessed by asking questions related to pain around the glandular tissue, glandular edema, presence of fevers, tenderness to palpation, foul taste in mouth or note purulent drainage, and overlying cervical skin erythema.
Time frame: From first injection through 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Jul 2022, 24 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
University of California, Davis →