About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo
- Ketamine Topical