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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00742 | Registry Identifier | NCI Trial ID | |
| CO09901 | Other Identifier | UWCCC |
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formulation/dose changes; planned changes to safety monitoring/reporting
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The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.25 mg phenylephrine | Experimental |
| |
| 2.5 mg phenylephrine | Experimental |
| |
| 5.0 mg phenylephrine | Experimental |
| |
| 10.0 mg phenylephrine | Experimental |
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| 20.0 mg phenylephrine | Experimental |
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| 40.0 mg phenylephrine | Experimental |
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| 60.0 mg phenylephrine | Experimental |
| |
| 80.0 mg phenylephrine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenylephrine solution | Drug | Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: the the mucositis severity area-under-the-curve (AUC) where the severity of oral mucositis on each treatment day will be scored, summed, and plotted graphically. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James F Cleary, MBBS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| Experimental |
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| D009057 |
| Stomatognathic Diseases |