Study Stopped
formulation/dose changes; planned changes to safety monitoring/reporting
Safety of Phenylephrine for Oral Mucositis Prevention
A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
3 other identifiers
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 28, 2020
December 1, 2020
8 months
March 23, 2010
December 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
24 months
Secondary Outcomes (1)
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
Study Arms (8)
1.25 mg phenylephrine
EXPERIMENTAL2.5 mg phenylephrine
EXPERIMENTAL5.0 mg phenylephrine
EXPERIMENTAL10.0 mg phenylephrine
EXPERIMENTAL20.0 mg phenylephrine
EXPERIMENTAL40.0 mg phenylephrine
EXPERIMENTAL60.0 mg phenylephrine
EXPERIMENTAL80.0 mg phenylephrine
EXPERIMENTALInterventions
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Eligibility Criteria
You may qualify if:
- cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes
- normal ECG
- normal blood pressure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James F Cleary, MBBS
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2010
First Posted
March 25, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2010
Study Completion
April 1, 2011
Last Updated
December 28, 2020
Record last verified: 2020-12