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Head and Neck CancerPhase 2NCT06660017

Head and Neck Cancer Patients With Oral Mucositis Treated With Ketamine Oral Rinse

A Phase 2 study testing Ketamine Topical in people with Head and Neck Cancer, run by University of Oklahoma at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Ketamine Topical
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteUnited States
Study dates
Dec 2026to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure.
  • At least 18 years-of-age at the time of signature of the informed consent form (ICF).
  • Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
  • The patients has received at least one radiation treatment for (HNSCC) the current disease.
  • CTCAE v. 5.0 grade 2 or greater oral cavity or pharyngeal mucositis documented to have developed after initiation of radiotherapy.
  • 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.

Who cannot join

  • Inability to sign an informed consent form.
  • Any other malignancy diagnosed or treated within 10 years prior to enrollment.
  • Any documented hypersensitivity to ketamine.
  • Contraindication for ketamine use, including allergy.
  • Patients with schizophrenia, acute psychosis, or any psychiatric disorder that could be dangerous if exacerbated.
  • 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.
Show all 10Show fewer
  • Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.
  • 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.
  • 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.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lead Nurse contact

405-271-8001 ext. 45403

SCC-IIT-Office@ouhsc.edu

United States1 site

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117

    Lead Nurse, 405-271-8777, SCC-IIT-Office@ouhsc.edu

    Rusha Patel, MD

Other trials in United States

About this study

Official title: Ketamine Oral Rinse in the Management of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy

This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment.

Read the detailed description

Patients with histologically proven head and neck cancer undergoing radiation or concurrent chemoradiation as part of their treatment plan, will either receive ketamine oral rinse or unmedicated oral rinse to use 4 times a day if they develop oral mucositis during their radiation.

Patients will be monitored during treatment and up to 30 days after and will utilize a pain diary to document daily.

Being tested
Placebo, Ketamine Topical
Keywords
Head and Neck Cancer, Ketamine, Oral Rinse, Radiation
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Patients in this arm will receive unmedicated syrup solution dispensed as 20mg/5ml 4 times a day in addition to receiving one of the following standard treatments; Magic Mouthwash, saliva substitute rinses, over-the-counter remedies including honey or salt and soda rinses, non-steroidal anti-inflammatory drugs (NSAIDS), or opioid medications.

  • Ketamine TopicalDrug

    Patients in this arm will receive ketamine oral rinse dispensed as 20mg/5ml 4 times a day in addition to receiving one of the following standard treatments; Magic Mouthwash, saliva substitute rinses, over-the-counter remedies including honey or salt and soda rinses, non-steroidal anti-inflammatory drugs (NSAIDS), or opioid medications.

Study groups in NCT06660017
Study groupRoleWhat they receive
Control GroupPlacebo comparatorTopical unmedicated syrup base + any standard treatment for oral mucositis.
Receives: Drug: Placebo
Intervention GroupExperimentalTopical ketamine in syrup + any standard treatment for oral mucositis.
Receives: Drug: Ketamine Topical

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse.

    Review weekly questionnaires of patients who received ketamine oral rinse to assess if it helped with the pain of mucositis caused by the radiation in head and neck cancer patients.

    Measured: 6 months

Secondary outcomes (3)

  1. Number of patients whose dysphagia was decreased by the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.

    Dysphagia as assessed by MDADI.

    Measured: 6 months.

  2. Number of patients whose quality-of-life increased after the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.

    Quality of life as assessed by FACT-HN.

    Measured: 6 months

  3. Number of patients who need morphine prescription equivalent reductions as a result of using ketamine oral rinse.

    Pain medication requirement measured in morphine equivalents.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study startDec 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be a control group and an intervention group in this study. The control group will receive an unmedicated syrup solution in addition to standard treatment for oral mucositis. The intervention group will receive ketamine oral rinse in addition to standard treatment for oral mucositis.
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660017
Sponsor's protocol ID
OU-SCC-KORAL
Status last verified
Oct 2026
First submitted
24 Oct 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketamine Topical in people with Head and Neck Cancer, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lead Nurse (405-271-8001 ext. 45403, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06660017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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