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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer, Oral Mucositis

Intervention / Treatment
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* Dietary Supplement: Grape extract
* Drug: Lortab, Fentanyl patch, mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Grape extract<br>Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy. | Dietary Supplement: Grape extract<br>* Grape extract self-administered by mouth daily for 35 days<br>|
| Active Comparator: 2 - Lortab, Fentanyl patch, mouthwash<br>Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels. | Drug: Lortab, Fentanyl patch, mouthwash<br>* Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash<br>* Other names: Mary's Magic Mouthwash;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Within three days of the completion of radiation therapy which will last approximately thirty days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response