Head and Neck Cancer, Oral Mucositis
Conditions
Keywords
Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTGrape extract
Grape extract self-administered by mouth daily for 35 days
DRUGLortab, Fentanyl patch, mouthwash
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain caused by oral mucositis | Total followup of six months | Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of immune biomarkers in blood | Within three days of the completion of radiation therapy which will last approximately 30 days. | Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels. |
| Level of immune biomarkers in mucosal tissue | Within three days of the completion of radiation therapy which will last approximately thirty days. | Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels. |
Countries
United States
Outcome results
None listed