Clinical trial NCT01263366: Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
Official title: Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Radiodermatitis
Keywords: Radiodermatitis
Prevention
Radiotherapy
Breast
Radiation Dermatitis
Lead sponsor: ProCertus BioPharm, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Wisconsin, Madison
First posted: 2010-12-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Safety of daily topical application of norepinephrine to the radiation field
timeFrame: 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:
measure: Efficacy of daily topical application of norepinephrine to the radiation field
timeFrame: 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.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: James F Cleary, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Bethany M Anderson, MD
role: STUDY_CHAIR
References:
citation: 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.