Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Stopped early · Phase 1

Conditions studied: Radiodermatitis

In brief

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.

Key facts

Study ID

NCT01263366

Run by

ProCertus BioPharm, Inc

People needed

10

Starts

2011-01-01

Expected to finish

2013-04-01

Last updated by the study team

2013-04-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects:
• with unhealed surgical wounds or scars in the study treatment area (axilla).
• with underlying active untreated cardiac disease (e.g. arrhythmia).
• with generalized skin disorders that have required treatment within the past 6 months.
• with connective tissue disorders.
• with rashes, ulcerations, or poorly healed scars in the study drug application area (axilla).
• with a known allergy to norepinephrine.
• with known uncontrolled hypertension (repeatedly elevated BP; systolic BP >139 or diastolic BP >89).
• with a known clinically significant abnormal ECG within the past 6 months.
• receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
• who are pregnant or breastfeeding.
• with lymphovascular space invasion on pathology.
• with dermal lymphatic invasion on pathology.
• with proximity of the tumor to the overlying skin as evidenced by a distance of less than 5 mm on US or MRI (if performed) and within 2 cm of the anticipated application field
• diagnosis of inflammatory breast cancer.
• receiving chemotherapy other than Herceptin concurrent with the radiation.
• with previous radiation to the breast to be treated.

Where it is running

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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