Safety of Phenylephrine for Oral Mucositis Prevention

This study has been terminated.
(formulation/dose changes; planned changes to safety monitoring/reporting)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01092975
First received: March 23, 2010
Last updated: May 24, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: phenylephrine solution
    Subjects will receive up to 40 dose of topical phenylephrine at one of the following dose levels: 1.25 mg; 2.5 mg; 5.0 mg; 10.0 mg; 20.0 mg; 40.0 mg; 60.0 mg and 80.0 mg
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: James F Cleary, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT01092975     History of Changes
Other Study ID Numbers: CO09901
Study First Received: March 23, 2010
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
radiotherapy

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

ClinicalTrials.gov processed this record on July 28, 2014