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NMDA Receptor Antagonist

Ketamine Oral Rinse for Mucositis

Phase 2

Waitlist Available

Led By Rusha Patel, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years-of-age at the time of signature of the informed consent form (ICF)

The patients has received at least one radiation treatment for (HNSCC) the current disease

Must not have

Inability to sign an informed consent form

Contraindication for ketamine use, including allergy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

"This trial aims to test if using a ketamine mouth rinse can help reduce pain in head and neck cancer patients receiving radiation treatment."

Who is the study for?

This trial is for head and neck cancer patients who are experiencing painful mouth ulcers (mucositis) due to radiation treatment. Specific eligibility criteria details were not provided, so interested individuals should inquire about the full inclusion and exclusion requirements.

What is being tested?

The study is testing if a ketamine oral rinse can relieve pain from mucositis compared to a placebo. It's a phase II trial with two groups: one receiving the ketamine rinse and the other receiving an inactive substance.

What are the potential side effects?

While specific side effects of ketamine oral rinse in this context aren't detailed, common ones may include taste changes, numbness inside the mouth, drowsiness, or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had radiation treatment for my head or neck cancer.

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I am receiving radiation or chemoradiation for head and neck cancer.

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I can take care of myself and am up and about more than half of my waking hours.

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I have severe mouth or throat sores from radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to sign a consent form.

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I am not allergic to ketamine.

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I do not have schizophrenia, acute psychosis, or any dangerous psychiatric disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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