Safety of Phenylephrine for Oral Mucositis Prevention

University of Wisconsin (UW)

Status and phase: Terminated; Phase 1

Conditions: Stomatitis; Mucositis

Treatments: Drug: phenylephrine solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01092975

NCI-2011-00742 (Registry Identifier)

CO09901 (Other Identifier)

H-2009-0077

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 8 patient groups

1.25 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

2.5 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

5.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

10.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

20.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

40.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

60.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution

80.0 mg phenylephrine

Experimental group

Treatment:

Drug: phenylephrine solution