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Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

NCT01544504 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-05-28

No results posted yet for this 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.

Conditions

  • Radiodermatitis

Interventions

DRUG

Norepinephrine

Approximately 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments).

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • ProCertus BioPharm, Inc

    lead INDUSTRY

Principal Investigators

  • Eleanor Harris, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01544504 on ClinicalTrials.gov