Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy|
- 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. ] [ Designated as safety issue: Yes ]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 for up to 11 weeks following the start of treatment.. ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Approximately 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments).
Other Name: Noradrenaline
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544504
|United States, Florida|
|H Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 333612|
|Principal Investigator:||Eleanor Harris, MD||H. Lee Moffitt Cancer Center and Research Institute|