Safety of Phenylephrine for Oral Mucositis Prevention

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes

Conditions
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Mucositis, Stomatitis

Intervention / Treatment
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* Drug: phenylephrine solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes normal ECG normal blood pressure Exclusion Criteria: untreated cardiac disease connective tissue disorders open sores, wound, ulcerations to oral cavity allergy to phenylephrine know untreated hypertensin abnormal ECG in past 6 months taking prescription monoamine oxidase inhibitor (MAOI) are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.25 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 2.5 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 5.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 10.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 20.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 40.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 60.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|
| Experimental: 80.0 mg phenylephrine<br> | Drug: phenylephrine solution<br>* Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy