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Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Primary Purpose

Radiodermatitis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Norepinephrine

About this trial

This is an interventional supportive care trial for Radiodermatitis focused on measuring Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Norepinephrine

Arm Description

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

NCT01263366

First Posted

December 16, 2010

Last Updated

April 17, 2013

Sponsor

ProCertus BioPharm, Inc

Collaborators

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01263366

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Enrollment issues

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProCertus BioPharm, Inc

Collaborators

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. 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.

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

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Norepinephrine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Norepinephrine

Other Intervention Name(s)

Noradrenaline

Intervention Description

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)

Primary Outcome Measure Information:

Title

Safety of daily topical application of norepinephrine to the radiation field

Description

Time Frame

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 Outcome Measure Information:

Title

Efficacy of daily topical application of norepinephrine to the radiation field

Description

Time Frame

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James F Cleary, MBBS

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bethany M Anderson, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Study Chair

Facility Information:

Facility Name

University of Wisconsin Carbone Cancer Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29273054

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.

Results Reference

derived

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Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

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