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Safety of Phenylephrine for Oral Mucositis Prevention

NCT ID: NCT01092975

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mucositis Stomatitis

Keywords

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radiotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1.25 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

2.5 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

5.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

10.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

20.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

40.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

60.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

80.0 mg phenylephrine

Group Type EXPERIMENTAL

phenylephrine solution

Intervention Type DRUG

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

Interventions

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phenylephrine solution

Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James F Cleary, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

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NCI-2011-00742

Identifier Type: REGISTRY

Identifier Source: secondary_id

CO09901

Identifier Type: OTHER

Identifier Source: secondary_id

H-2009-0077

Identifier Type: -

Identifier Source: org_study_id