Status:
COMPLETED
Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Breast Cancer
Dermatitis
Eligibility:
FEMALE
18+ years
Brief Summary
The investigators plan to investigate the protective effects of topical sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in women undergoing external-beam radiati...
Eligibility Criteria
Inclusion
- Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast.
- Patients must have undergone segmental mastectomy (i.e., lumpectomy).
- Patients must not have received prior radiation therapy to the breast.
- Patients must not have active local-regional disease prior to registration.
- Patients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy.
- Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- Visible skin pathology, excessive freckles, or skin blemishes in the test area.
- History of skin disease or hypersensitivity and repeated contact allergies.
- Sarcoma or squamous cell histology.
- Metastatic disease to the breast.
- Current tobacco use.
Key Trial Info
Start Date :
April 15 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00894712
Start Date
April 15 2009
End Date
November 15 2012
Last Update
May 7 2019
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21231