Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

NCT01544504 | Withdrawn Phase 1

• 1 other identifier: PC-6
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 for up to 11 weeks following the start of treatment.

Secondary Outcomes (1)

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

  Efficacy will be assessed for up to 11 weeks following the start of treatment..

Study Arms (1)

Norepinephrine

EXPERIMENTAL

Topical norepinephrine

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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).

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 qualify if:

• 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), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB (T2N1M0, T3N0M0) 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 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.
• 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 \[breast size criterion\].
• 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.

You may not qualify if:

• Subjects:
• with unhealed surgical wounds or scars in the study treatment area.
• 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.
• with a known allergy to norepinephrine.
• 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).
• 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 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.
• receiving concurrent neoadjuvant or adjuvant chemotherapy for their breast cancer.
• with previous radiation to the breast to be treated.

Sponsors & Collaborators

• ProCertus BioPharm, Inc: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 333612, United States

Location

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

• Eleanor Harris, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 6, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (1)