Could a ketamine mouthwash ease radiation mouth pain?
NCT ID NCT06660017
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- New PET tracer aims to light up hidden cancer targets
- Can immunotherapy before surgery stop early oral cancer from returning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Can a glowing dye show surgeons where head and neck tumors end?
- Re-irradiation plus cetuximab targets head and neck tumors that return