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


Phase 1
18 Years
N/A
Not Enrolling
Female
Radiodermatitis

Thank you

Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

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

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 during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.

Safety Issue:

Yes

Principal Investigator

James F Cleary, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

PC-4

NCT ID:

NCT01263366

Start Date:

January 2011

Completion Date:

April 2013

Related Keywords:

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

Name

Location

University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669