Safety of Phenylephrine for Oral Mucositis Prevention

Phase 1TerminatedNCT01092975

University of Wisconsin, Madison1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Mucositis Stomatitis

Interventions

phenylephrine solutionDRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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