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Grape

Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.

Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.

Grape extract self-administered by mouth daily for 35 days

Grape extract

Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash

Lortab, Fentanyl patch, mouthwash

Rebecca Redman, MD

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.

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

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

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.

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.

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.

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer	NCT01668849	Head and Neck C... Oral Mucositis	Grape extract Lortab, Fentany...	20 Years - 85 Years	University of Louisville
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer	NCT01668849	Head and Neck C... Oral Mucositis	Grape extract Lortab, Fentany...	20 Years - 85 Years	University of Louisville

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