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. ]
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. ]
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