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

NCT06660017 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OU-SCC-KORAL
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Ketamine; Oral Rinse; Radiation

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (3)

• 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.

• 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

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

  6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Topical unmedicated syrup base + any standard treatment for oral mucositis.

Drug: Placebo

Intervention Group

EXPERIMENTAL

Topical ketamine in syrup + any standard treatment for oral mucositis.

Drug: Ketamine Topical

Interventions

Placebo DRUG

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.

Control Group

Ketamine Topical DRUG

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rusha Patel, MD

  OU Health Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Nurse

CONTACT

405-271-8001; SCC-IIT-Office@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The principal investigator and pharmacist will be the only ones who are aware of whom gets which arm of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (1)