Back to resultsExploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
Primary Purpose
Radiodermatitis
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Norepinephrine
Sponsored by
About this trial
This is an interventional prevention trial for Radiodermatitis focused on measuring Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis
Eligibility Criteria
Inclusion 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), 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.
Exclusion Criteria:
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.
- taking β-blockers.
- with NCI CTC Version 4.0 grade 2 or higher hypertension at the time of study entry.
Sites / Locations
- H Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Norepinephrine
Arm Description
Topical norepinephrine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Efficacy of daily topical application of norepinephrine to the radiation field
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.
Full Information
NCT ID
NCT01544504
First Posted
February 15, 2012
Last Updated
May 25, 2012
Sponsor
ProCertus BioPharm, Inc
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01544504
Brief Title
Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
Official Title
Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The principal investigator withdrew from the study. The study was withdrawn because a qualified replacement was not available.
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProCertus BioPharm, Inc
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis
Keywords
Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norepinephrine
Arm Type
Experimental
Arm Description
Topical norepinephrine
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Noradrenaline
Intervention Description
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).
Primary Outcome Measure Information:
Title
Safety of daily topical application of norepinephrine to the radiation field
Description
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.
Time Frame
Safety will be assessed for up to 11 weeks following the start of treatment.
Secondary Outcome Measure Information:
Title
Efficacy of daily topical application of norepinephrine to the radiation field
Description
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.
Time Frame
Efficacy will be assessed for up to 11 weeks following the start of treatment..
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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), 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.
Exclusion Criteria:
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.
taking β-blockers.
with NCI CTC Version 4.0 grade 2 or higher hypertension at the time of study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Harris, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
333612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
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