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Safety of Phenylephrine for Oral Mucositis Prevention

This study has been terminated.
(formulation/dose changes; planned changes to safety monitoring/reporting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092975
First Posted: March 25, 2010
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention Phase
Mucositis Stomatitis Drug: phenylephrine solution Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.25 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 2.5 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 5.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 10.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 20.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 40.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 60.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Experimental: 80.0 mg phenylephrine Drug: phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092975


Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: James F Cleary, MBBS University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01092975     History of Changes
Other Study ID Numbers: CO09901
First Submitted: March 23, 2010
First Posted: March 25, 2010
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by University of Wisconsin, Madison:
radiotherapy

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents