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NCT Number: NCT07802977

Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia

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.

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Key information

Conditions

Xerostomia Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Davis, Department of Otolaryngology

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events

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

    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.

  2. Patient Tolerance of Injection Procedure

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

    Assessment of patient tolerance during and after each ultrasound-guided intraparenchymal dexamethasone injection procedure.

  3. 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

    Feasibility assessment of the ability to successfully inject 1cc of dexamethasone solution into multiple salivary glands (up to 4) as planned per protocol.

Other outcomes

  1. Salivary Flow Rate (Unstimulated and Stimulated)

    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

    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).

  2. Score on the Visual Analogue Scale (VAS) Xerostomia Questionnaire

    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

    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).

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

    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

    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).

  4. Change in Salivary Gland Volume on CT/PET Imaging

    Time frame: Baseline (pre-treatment) and 12-18 weeks post-treatment

    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.

  5. Incidence of Sialadenitis

    Time frame: From first injection through 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Intraglandular Salivary Corticosteroid Injections to Prevent Radiation-Induced Xerostomia: A Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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