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Could a ketamine mouthwash ease radiation mouth pain?

NCT ID NCT06660017

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests if a ketamine oral rinse can relieve pain from mouth sores (mucositis) caused by radiation therapy in head and neck cancer patients. About 62 adults receiving radiation will use the rinse and report their pain levels. The goal is to see if this simple rinse improves comfort and quality of life during cancer treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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 99 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: 1. Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure. 2. At least 18 years-of-age at the time of signature of the informed consent form (ICF). 3. Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2. 5. The patients has received at least one radiation treatment for (HNSCC) the current disease. 6. CTCAE v. 5.0 grade 2 or greater oral cavity or pharyngeal mucositis documented to have developed after initiation of radiotherapy. 7. Males or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Male patients must also refrain from donating sperm during participation in the study. Exclusion Criteria: 1. Inability to sign an informed consent form. 2. Any other malignancy diagnosed or treated within 10 years prior to enrollment. 3. Any documented hypersensitivity to ketamine. 4. Contraindication for ketamine use, including allergy. 5. Patients with schizophrenia, acute psychosis, or any psychiatric disorder that could be dangerous if exacerbated. 6. Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least \<\<6\>\> months after the last administration of study treatment. 7. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment. 8. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. 9. Patients with a prior or concurrent malignancy whole natural history or treatment does not have potential to interfere with the safety or efficacy assessment of the investigational regimen should be included. 10. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117, United States

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Other studies related to the condition(s) this trial covers.