TerminatedPhase 1

Safety of Phenylephrine for Oral Mucositis Prevention

Stopped: formulation/dose changes; planned changes to safety monitoring/reporting

United States1 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT01092975

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

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