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Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

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

NCT01544504•ProCertus BioPharm, Inc

View on ClinicalTrials.gov

Summary

This study, a nonrandomized open-label 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subjects must:
•1. be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB (T2N1M0, T3N0M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
•2. be post-surgical patients scheduled to be treated with at least 50 Gy to the whole breast and axilla using standard 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.
•3. be at higher than average risk for radiodermatitis, as evidenced by a separation at the posterior tangent field border of ≥ 24 cm or a bra cup size of C or greater \[breast size criterion\].
•4. have the ability to understand the informed consent document.
•5. be able to comply with protocol schedule.
•6. have a negative serum pregnancy test (within 7 days prior to starting radiation therapy), if a female of child bearing potential.
•7. consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential.

Exclusion Criteria

•Subjects:
•1. with unhealed surgical wounds or scars in the study treatment area.
•2. with underlying active untreated cardiac disease (e.g. arrhythmia).
•3. with generalized skin disorders that have required treatment within the past 6 months.
•4. with connective tissue disorders.
•5. with rashes, ulcerations, or poorly healed scars in the study drug application area.
•6. with a known allergy to norepinephrine.
•7. with a known clinically significant abnormal ECG within the past 6 months. If the Principal Investigator feels that the ECG findings are of clinical significance, the patient will excluded or sent for a cardiac consult (insignificant abnormalities such as sinus tachycardia and sinus bradycardia may be allowed at the discretion of the Principal Investigator).
•8. receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
•9. who are pregnant or breastfeeding.
+7 more criteria

Locations (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

May 28, 2012

Conditions

Radiodermatitis

Interventions

Norepinephrine

DRUG

The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.

NCT05561803

Radiodermatitis; AcuteRadiotherapy Side Effect+2 more

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UNKNOWNNA

Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy

NCT05535452

Radiodermatitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

Inclusion Criteria

Exclusion Criteria

The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.

Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy

Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer

Preventive Effect of Boron-based Gel on Radiation Dermatitis

Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma Receiving IMRT