Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

NCT01263366 | Terminated Phase 1

• 1 other identifier: PC-4
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiodermatitis

Keywords

Radiodermatitis; Prevention; Radiotherapy; Breast; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Safety of daily topical application of norepinephrine to the radiation field

  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 Outcomes (1)

• Efficacy of daily topical application of norepinephrine to the radiation field

  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.

Study Arms (1)

Norepinephrine

EXPERIMENTAL

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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)

Also known as: Noradrenaline

Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProCertus BioPharm, Inc: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Cleary JF, Anderson BM, Eickhoff JC, Khuntia D, Fahl WE. Significant suppression of radiation dermatitis in breast cancer patients using a topically applied adrenergic vasoconstrictor. Radiat Oncol. 2017 Dec 22;12(1):201. doi: 10.1186/s13014-017-0940-7.

  PMID: 29273054 DERIVED

MeSH Terms

Conditions

Radiodermatitis

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• James F Cleary, MBBS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Bethany M Anderson, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 20, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

US (1)