Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

April 17, 2013 updated by: ProCertus BioPharm, Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Norepinephrine
Drug: Norepinephrine
Approximately 1.6 or 4.6 mL of a 400 mM norepinephrine solution will be applied topically to a portion of the radiation treatment field prior to each radiation treatment (20-33 treatments)
Other Names:
  • Noradrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of daily topical application of norepinephrine to the radiation field
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of daily topical application of norepinephrine to the radiation field
Time Frame: Efficacy 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.
The primary efficacy hypothesis is that the portion of the radiation site that is treated with topical norepinephrine immediately prior to daily radiotherapy will have less severe radiation dermatitis than the adjacent untreated portion of the radiation site.
Efficacy 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProCertus BioPharm, Inc

Collaborators

University of Wisconsin, Madison

Investigators

  • Principal Investigator: James F Cleary, MBBS, University of Wisconsin, Madison
  • Study Chair: Bethany M Anderson, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 20, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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