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Safety of Phenylephrine for Oral Mucositis Prevention

Primary Purpose

Mucositis, Stomatitis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
phenylephrine solution
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mucositis focused on measuring radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1.25 mg phenylephrine

2.5 mg phenylephrine

5.0 mg phenylephrine

10.0 mg phenylephrine

20.0 mg phenylephrine

40.0 mg phenylephrine

60.0 mg phenylephrine

80.0 mg phenylephrine

Arm Description

Outcomes

Primary Outcome Measures

Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.

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.

Full Information

First Posted
March 23, 2010
Last Updated
December 23, 2020
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01092975
Brief Title
Safety of Phenylephrine for Oral Mucositis Prevention
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
formulation/dose changes; planned changes to safety monitoring/reporting
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Stomatitis
Keywords
radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.25 mg phenylephrine
Arm Type
Experimental
Arm Title
2.5 mg phenylephrine
Arm Type
Experimental
Arm Title
5.0 mg phenylephrine
Arm Type
Experimental
Arm Title
10.0 mg phenylephrine
Arm Type
Experimental
Arm Title
20.0 mg phenylephrine
Arm Type
Experimental
Arm Title
40.0 mg phenylephrine
Arm Type
Experimental
Arm Title
60.0 mg phenylephrine
Arm Type
Experimental
Arm Title
80.0 mg phenylephrine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
phenylephrine solution
Intervention Description
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
Primary Outcome Measure Information:
Title
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F Cleary, MBBS
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

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Safety of Phenylephrine for Oral Mucositis Prevention

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