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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Total followup of six months
Donald M Miller, MD, PhD
James Graham Brown Cancer Center, University of Louisville
United States: Institutional Review Board
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|