Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
Information source: ProCertus BioPharm, Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Radiodermatitis
Intervention: Norepinephrine (Drug)
Phase: Phase 1/Phase 2
Status: Withdrawn
Sponsored by: ProCertus BioPharm, Inc Official(s) and/or principal investigator(s): Eleanor Harris, MD, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Clinical Details
Official title: Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Safety of daily topical application of norepinephrine to the radiation field
Secondary outcome: Efficacy of daily topical application of norepinephrine to the radiation field
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Subjects must:
1. be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1,
N0, M0), Stage Ib (T0 or 1, N1mic, M0), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB
(T2N1M0, T3N0M0) infiltrating ductal or lobular carcinoma of the breast or ductal
carcinoma in situ (DCIS).
2. be post-surgical patients scheduled to be treated with at least 50 Gy to the whole
breast and axilla using standard 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.
3. be at higher than average risk for radiodermatitis, as evidenced by a separation at
the posterior tangent field border of ≥ 24 cm or a bra cup size of C or greater
[breast size criterion].
4. have the ability to understand the informed consent document.
5. be able to comply with protocol schedule.
6. have a negative serum pregnancy test (within 7 days prior to starting radiation
therapy), if a female of child bearing potential.
7. consent to utilize medically acceptable methods of contraception throughout the study
period if of child-bearing potential.
Exclusion Criteria:
Subjects:
1. with unhealed surgical wounds or scars in the study treatment area.
2. with underlying active untreated cardiac disease (e. g. arrhythmia).
3. with generalized skin disorders that have required treatment within the past 6
months.
4. with connective tissue disorders.
5. with rashes, ulcerations, or poorly healed scars in the study drug application area.
6. with a known allergy to norepinephrine.
7. with a known clinically significant abnormal ECG within the past 6 months. If the
Principal Investigator feels that the ECG findings are of clinical significance, the
patient will excluded or sent for a cardiac consult (insignificant abnormalities such
as sinus tachycardia and sinus bradycardia may be allowed at the discretion of the
Principal Investigator).
8. receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
9. who are pregnant or breastfeeding.
10. with lymphovascular space invasion on pathology.
11. with dermal lymphatic invasion on pathology.
12. with close proximity of the tumor to the overlying skin within the SDAS (as evidenced
by a depth of less than 5 mm on ultrasound or MRI [if performed] and a linear
distance of less than 2 cm from the SDAS), or a diagnosis of inflammatory breast
cancer.
13. receiving concurrent neoadjuvant or adjuvant chemotherapy for their breast cancer.
14. with previous radiation to the breast to be treated.
15. taking β-blockers.
16. with NCI CTC Version 4. 0 grade 2 or higher hypertension at the time of study entry.
Locations and Contacts
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 333612, United States
Additional Information
Starting date: March 2012
Last updated: May 25, 2012
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