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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Grape extract | Experimental | Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy. |
|
| 2 - Lortab, Fentanyl patch, mouthwash | Active Comparator | Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grape extract | Dietary Supplement | Grape extract self-administered by mouth daily for 35 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Redman, MD | James Graham Brown Cancer Center, University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29054476 | Derived | Wu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18. |
| Label | URL |
|---|---|
| James Graham Brown Cancer Center, Louisville, Kentucky | View source |
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| Lortab, Fentanyl patch, mouthwash | Drug | Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash |
|
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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. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000722782 | whole grape extract |
| C514822 | oxycodone-acetaminophen |
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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