Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

This study has been terminated.
(Enrollment issues)
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier:
NCT01263366
First received: December 16, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Radiodermatitis
Drug: Norepinephrine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy

Resource links provided by NLM:


Further study details as provided by ProCertus BioPharm, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Noradrenaline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263366

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
ProCertus BioPharm, Inc
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
  More Information

No publications provided

Responsible Party: ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier: NCT01263366     History of Changes
Other Study ID Numbers: PC-4
Study First Received: December 16, 2010
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ProCertus BioPharm, Inc:
Radiodermatitis
Prevention
Radiotherapy
Breast
Radiation Dermatitis

Additional relevant MeSH terms:
Breast Neoplasms
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Dermatitis
Radiation Injuries
Wounds and Injuries
Norepinephrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014