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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Acetaminophen, hydrocodone drug combination; Fentanyl

Criteria

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