Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Radiodermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01263366
• Other study ID #: PC-4
• Status: Terminated
• Phase: Phase 1
• First received: December 16, 2010
• Last updated: April 17, 2013
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: ProCertus BioPharm, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Radiodermatitis

Intervention

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)

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
ProCertus BioPharm, Inc	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.	Yes
Secondary	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.	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.	No