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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Grape extract self-administered by mouth daily for 35 days
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Pain caused by oral mucositis
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.
Time frame: Total followup of six months
Level of immune biomarkers in blood
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.
Time frame: Within three days of the completion of radiation therapy which will last approximately 30 days.
Level of immune biomarkers in mucosal tissue
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.
Time frame: Within three days of the completion of radiation therapy which will last approximately thirty days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.