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Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

NCT01263366 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-04-19

No results posted yet for this study

Summary

This study, a nonrandomized open-label Phase I 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.

Conditions

  • Radiodermatitis

Interventions

DRUG

Norepinephrine

Approximately 1.6 or 4.6 mL of a 400 mM norepinephrine solution will be applied topically to a portion of the radiation treatment field prior to each radiation treatment (20-33 treatments)

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • ProCertus BioPharm, Inc

    lead INDUSTRY

Principal Investigators

  • James F Cleary, MBBS · University of Wisconsin, Madison

  • Bethany M Anderson, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263366 on ClinicalTrials.gov