- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092975
Safety of Phenylephrine for Oral Mucositis Prevention
December 23, 2020 updated by: University of Wisconsin, Madison
A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1.25 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 2.5 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 5.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 10.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 20.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 40.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 60.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
Experimental: 80.0 mg phenylephrine
|
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome 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.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James F Cleary, MBBS, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 24, 2010
First Posted (Estimate)
March 25, 2010
Study Record Updates
Last Update Posted (Actual)
December 28, 2020
Last Update Submitted That Met QC Criteria
December 23, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Mucositis
- Stomatitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- H-2009-0077
- NCI-2011-00742 (Registry Identifier: NCI Trial ID)
- CO09901 (Other Identifier: UWCCC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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