Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients

Inclusion Criteria:

- Patients must have definitive diagnosis of head and neck cancer.

- Concurrent chemoradiation treatment of the primary tumor must be an option for the
newly diagnosed cancer.

- Patients must be informed of the investigational nature of this study and sign and
give written informed consent in accordance with institutional and federal
guidelines.

- Absence of life limiting medical conditions

- Ability to understand and willingness to sign a written informed consent document.

- ECOG performance status 0, 1, or 2 (Karnofsky > 60%).

- Patients must have adequate bone marrow function. ANC > 1000/microL and Platelet
count >100,000/microL

- Age >20 years

Exclusion Criteria:

- Known familial head and neck cancer syndrome

- Pregnancy

- Known HIV

- Patients receiving immunosuppressive drugs

- Inflammatory bowel disease

- Active second malignancy in the last 5 years

- Patients receiving any other investigational agent(s)

- Patients who have received any prior chemotherapy or radiation therapy to the primary
head and neck cancer