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Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Information source: ProCertus BioPharm, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Radiodermatitis

Intervention: Norepinephrine (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: ProCertus BioPharm, Inc

Official(s) and/or principal investigator(s):
James F Cleary, MBBS, Principal Investigator, Affiliation: University of Wisconsin, Madison
Bethany M Anderson, MD, Study Chair, Affiliation: University of Wisconsin, Madison

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.

Clinical Details

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

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

Primary outcome: Safety of daily topical application of norepinephrine to the radiation field

Secondary outcome: Efficacy of daily topical application of norepinephrine to the radiation field

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin 53792, United States
Additional Information

Starting date: January 2011
Last updated: April 17, 2013

Page last updated: August 23, 2015

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