Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

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

This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these 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