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

Phase 2

Not yet recruiting

• Conditions: Head and Neck Cancer
• Interventions: Drug: Placebo; Drug: Ketamine Topical

• Registration Number: NCT06660017
• Lead Sponsor: University of Oklahoma

Brief 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.

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11
• Primary Completion: 2026-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Topical unmedicated syrup base + any standard treatment for oral mucositis.
Intervention Group	Ketamine Topical	Topical ketamine in syrup + any standard treatment for oral mucositis.

Primary Outcome Measures

Name	Time	Method
Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients whose dysphagia was decreased by the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.	6 months.	Dysphagia as assessed by MDADI.
Number of patients whose quality-of-life increased after the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.	6 months	Quality of life as assessed by FACT-HN.
Number of patients who need morphine prescription equivalent reductions as a result of using ketamine oral rinse.	6 months	Pain medication requirement measured in morphine equivalents.

Trial Locations

Locations (1)

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States