Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT01263366|
Recruitment Status : Terminated (Enrollment issues)
First Posted : December 20, 2010
Last Update Posted : April 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiodermatitis||Drug: Norepinephrine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Approximately 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)
Other Name: Noradrenaline
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263366
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||James F Cleary, MBBS||University of Wisconsin, Madison|
|Study Chair:||Bethany M Anderson, MD||University of Wisconsin, Madison|