Clinical Trials Directory

Trials / Terminated

TerminatedNCT01263366

Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
10 (actual)
Sponsor
ProCertus BioPharm, Inc · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGNorepinephrineApproximately 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)

Timeline

Start date
2011-01-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2010-12-20
Last updated
2013-04-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01263366. Inclusion in this directory is not an endorsement.