Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
- Registration Number
- NCT01263366
- Lead Sponsor
- ProCertus BioPharm, Inc
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Norepinephrine Norepinephrine -
- Primary Outcome Measures
Name Time Method Safety of daily topical application of norepinephrine to the radiation field 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.
- Secondary Outcome Measures
Name Time Method Efficacy of daily topical application of norepinephrine to the radiation field 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.
Trial Locations
- Locations (1)
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States