Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

This study has been withdrawn prior to enrollment.
(The principal investigator withdrew from the study. The study was withdrawn because a qualified replacement was not available.)
Sponsor:
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier:
NCT01544504
First received: February 15, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

This study, a nonrandomized open-label 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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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 for up to 11 weeks following the start of treatment. ] [ 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 for up to 11 weeks following the start of treatment.. ] [ 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: 0
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norepinephrine
Topical norepinephrine
Drug: Norepinephrine
Approximately 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments).
Other Name: Noradrenaline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

Subjects:

  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 months.
  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 cancer.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544504

Locations
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 333612
Sponsors and Collaborators
ProCertus BioPharm, Inc
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Eleanor Harris, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier: NCT01544504     History of Changes
Other Study ID Numbers: PC-6
Study First Received: February 15, 2012
Last Updated: May 25, 2012
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 April 16, 2014