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Norepinephrine for Radiation Dermatitis

Phase 1 & 2
Waitlist Available
Led By Eleanor Harris, MD
Research Sponsored by ProCertus BioPharm, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up safety will be assessed for up to 11 weeks following the start of treatment.
Awards & highlights

Study Summary

This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy. The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety will be assessed for up to 11 weeks following the start of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety will be assessed for up to 11 weeks following the start of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of daily topical application of norepinephrine to the radiation field
Secondary outcome measures
Efficacy of daily topical application of norepinephrine to the radiation field

Side effects data

From 2015 Phase 4 trial • 85 Patients • NCT02354833
63%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phenylephrine
Norepinephrine

Trial Design

1Treatment groups
Experimental Treatment
Group I: NorepinephrineExperimental Treatment1 Intervention
Topical norepinephrine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norepinephrine
FDA approved

Find a Location

Who is running the clinical trial?

ProCertus BioPharm, IncLead Sponsor
2 Previous Clinical Trials
13 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
549 Previous Clinical Trials
135,710 Total Patients Enrolled
Eleanor Harris, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
~0 spots leftby Jul 2025
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