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Safety of Phenylephrine for Oral Mucositis Prevention

University of Wisconsin (UW) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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