Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Radiodermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Norepinephrine

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Noradrenaline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No