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Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy

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:


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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety of daily topical application of norepinephrine to the radiation field

Outcome Description:

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.

Outcome Time Frame:

Safety will be assessed for up to 11 weeks following the start of treatment.

Safety Issue:


Principal Investigator

Eleanor Harris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

May 2012

Related Keywords:

  • Radiodermatitis
  • Radiodermatitis
  • Prevention
  • Radiotherapy
  • Breast
  • Radiation Dermatitis
  • Breast Neoplasms
  • Radiodermatitis



H Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612