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Can steroid shots shield salivary glands from radiation damage?

NCT ID NCT07802977

Disease control Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This pilot study tests whether injecting a corticosteroid called dexamethasone directly into the salivary glands can prevent dry mouth in people receiving radiation therapy for head and neck cancer. Researchers will enroll 10 adults with certain types of throat cancer who are scheduled for radiation, with or without chemotherapy. The main goal is to see if the injections are practical and safe, meaning they do not cause missed or delayed radiation sessions or serious side effects. The study also looks at whether the treatment helps maintain saliva production and reduces dry mouth symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone injections into the salivary glands
What this could lead to
If this approach works, it could offer a way to protect salivary glands during radiation therapy, reducing long-term dry mouth and improving quality of life for head and neck cancer patients.
What could go wrong
This is a small pilot study with only 10 participants, so results may not apply broadly. The injections could cause pain, swelling, or other side effects, and the treatment might not effectively prevent dry mouth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Jul 2020

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma nasopharyngeal squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck Xerostomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma Xerostomia

Contacts and locations

Locations

  • University of California, Davis, Department of Otolaryngology

    Sacramento, California, 95817, United States

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