Safety of Phenylephrine for Oral Mucositis Prevention
- Registration Number
- NCT01092975
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2.5 mg phenylephrine phenylephrine solution - 1.25 mg phenylephrine phenylephrine solution - 20.0 mg phenylephrine phenylephrine solution - 40.0 mg phenylephrine phenylephrine solution - 60.0 mg phenylephrine phenylephrine solution - 10.0 mg phenylephrine phenylephrine solution - 80.0 mg phenylephrine phenylephrine solution - 5.0 mg phenylephrine phenylephrine solution -
- Primary Outcome Measures
Name Time Method Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States