Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
Head and Neck Cancer - Oral Mucositis
Conditions: official terms
Head and Neck Neoplasms - Mucositis - Stomatitis
Conditions: Keywords
Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response
Study Type
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Grape extract Type: Dietary Supplement
Name: Lortab, Fentanyl patch, mouthwash Type: Drug
Overall Status
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 20 Years
Gender: Both
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
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Status: Recruiting
Contact: Rebecca Redman, MD - 502-562-3429 - r.redman@louisville.edu
Start Date
August 2012
Completion Date
August 2017
James Graham Brown Cancer Center
James Graham Brown Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page