Clinical Trial: Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: ProCertus BioPharm, Inc

Current Primary Outcome: Safety of daily topical application of norepinephrine to the radiation field [ Time Frame: Safety will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period. ]

The primary safety hypothesis is that there will be little or no skin irritation associated with the application of the topical norepinephrine and no systemic effects secondary to transdermal absorption.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of daily topical application of norepinephrine to the radiation field [ Time Frame: Efficacy will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period. ]

The primary efficacy hypothesis is that the portion of the radiation site that is treated with topical norepinephrine immediately prior to daily radiotherapy will have less severe radiation dermatitis than the adjacent untreated portion of the radiation site.


Original Secondary Outcome: Same as current

Information By: ProCertus BioPharm, Inc

Dates:
Date Received: December 16, 2010
Date Started: January 2011
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013