Spots Global Cancer Trial Database for Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT01668849

Conditions

Head and Neck Cancer

Oral Mucositis

Interventions

Grape extract

Lortab, Fentanyl patch, mouthwash

Study Description

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.