Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer

We would like to determine the effectiveness of ketamine mouthwash in providing pain relief
to subjects with head and neck cancer suffering from mucositis, a common adverse event of
radiation therapy and chemoradiation therapy. Ketamine is a schedule III controlled substance
that is generally used to provide anesthesia for short diagnostic and surgical procedures.

Ten subjects will be randomized to two treatment arms. Group A will receive ketamine on
Monday, placebo on Wednesday, and ketamine on Friday. Group B will receive placebo on Monday,
ketamine on Wednesday, and placebo on Friday. Each subject will swish the study drug or
placebo for 2 minutes and spit it out. The use of non-maintenance mucositis medications such
as DLM solution will not be allowed during the clinic visit. Subjects may resume
non-maintenance mucositis medications at home.

Subjects will be asked to document adverse effects and pain scores at 30, 45, and 60 minutes
after study medication. The Richmond Agitation and Sedation Scale (RASS) will be used to
determine a subject's sedation level, if necessary. Treatment will last for up to 6 weeks
unless an illness or an event occurs that prevents continuation, intolerance to the agent,
adverse events, resolution of mucositis pain, or the decision to withdraw from the study.

Inclusion Criteria:

- Subjects diagnosed with head and neck tumors (any histology) receiving ongoing
chemoradiation or radiation therapy

- Subjects with mucositis pain refractory to topical management, defined as any
self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of
topical agents as prescribed

- Age ≥ 18 years

- Ability to understand and willingness to consent and to sign consent form

Exclusion Criteria:

- Active substance abuse at time of registration (alcohol, drugs, non-prescription use
of controlled substances)

- Subjects with history of allergic reactions to ketamine

- Persistent oral bleeding: > 15 mL (estimated) per day

- Pregnancy or breast feeding