Mucositis, Stomatitis
Conditions
Keywords
radiotherapy
Brief summary
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.
Interventions
DRUGphenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. | 24 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed