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

NCT ID: NCT06660017

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2027-11-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Intervention Group

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

Group Type: EXPERIMENTAL

Ketamine Topical

Intervention Type: 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.

Interventions

Placebo

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.

Intervention Type: DRUG

Ketamine Topical

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 Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rusha Patel, MD

Role: PRINCIPAL_INVESTIGATOR

OU Health Stephenson Cancer Center

Locations

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Lead Nurse

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8001 ext. 45403

Facility Contacts

Lead Nurse

Role: primary

SCC-IIT-Office@ouhsc.edu

405-271-8777

Other Identifiers

OU-SCC-KORAL

Identifier Type: -

Identifier Source: org_study_id