Clinical Trial: Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
Study Status: Withdrawn
Recruit Status: Withdrawn
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 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 for up to 11 weeks following the start of treatment. ]
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 for up to 11 weeks following the start of treatment.. ]
Original Secondary Outcome: Same as current
Information By: ProCertus BioPharm, Inc
Dates:
Date Received: February 15, 2012
Date Started: March 2012
Date Completion:
Last Updated: May 25, 2012
Last Verified: May 2012