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

  • United States
    • 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
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.

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

University of Wisconsin, Madison

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

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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