Ketamine Oral Rinse in the Management of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy
University of Oklahoma
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.
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 muc…
Interventions
- DrugPlacebo
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.
- DrugKetamine 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.
Location
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma