Status:
TERMINATED
Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
Lead Sponsor:
ProCertus BioPharm, Inc
Collaborating Sponsors:
University of Wisconsin, Madison
Conditions:
Radiodermatitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 the...
Eligibility Criteria
Inclusion
- Eligibility Criteria
- Subjects must:
- be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0) or Stage IIa (T\<3cm, N0, M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
- be post-surgical patients scheduled to be treated with at least 40 to 50.4 Gy to the whole breast and axilla using either standard or hypofractionated radiation techniques . An additional 10-16 Gy boost to the lumpectomy region may also be delivered. All radiation treatment is to be delivered based on standard CT planning.
- have the ability to understand the informed consent document.
- be able to comply with protocol schedule.
- have a negative serum pregnancy test (within 7 days prior to starting radiation therapy), if a female of child bearing potential.
- consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01263366
Start Date
January 1 2011
End Date
April 1 2013
Last Update
April 19 2013
Active Locations (1)
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1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792