Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Sponsor

ProCertus BioPharm, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT01263366

Collaborator

University of Wisconsin, Madison (Other)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiodermatitis	Drug: Norepinephrine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Norepinephrine	Drug: Norepinephrine 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) Other Names: Noradrenaline

Arm

Intervention/Treatment

Experimental: Norepinephrine

Drug: Norepinephrine

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)

Other Names:

Noradrenaline

Outcome Measures

Primary Outcome Measures

Safety of daily topical application of norepinephrine to the radiation field [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.]
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 [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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.