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

Prior treatment

• Any other malignancy diagnosed or treated within 10 years prior to enrollment.
• 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.

Other illness

• 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.
• 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.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Other

• Inability to sign an informed consent form.
• 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.

• 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.