Safety of Phenylephrine for Oral Mucositis Prevention

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01092975
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 8
• Duration (Months): 13
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mucositis; Stomatitis	Drug: phenylephrine solution	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• 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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. [24 months]

Secondary Outcome Measures

1. 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. [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Wisconsin Carbone Cancer Center

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01092975
• Other Study ID Numbers: H-2009-0077; NCI-2011-00742; CO09901
• First Posted: Mar 25, 2010
• Last Update Posted: Dec 28, 2020
• Last Verified: Dec 1, 2020

• Keywords provided by University of Wisconsin, Madison: radiotherapy
• Additional relevant MeSH terms: Mucositis; Stomatitis; Phenylephrine; Oxymetazoline

Study Results

No Results Posted as of Dec 28, 2020