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NCT00894712 · ClinicalTrials.gov registry record
Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis
A clinical trial, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- 12
- Enrollment target
NCT00894712 is a clinical trial that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 12 participants.
The verdict
NCT00894712 has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study 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 radiation therapy for breast cancer. Topical sulforaphane induces phase 2 enzymes that are protective against oxidants, electrophiles, and inflammation (Talalay and Fahey, 2001) - all of which are generated by both ultraviolet and ionizing radiation. Previous work from the investigators' group demonstrated that sulforaphane treatment protects against ultraviolet radiation-induced erythema of human skin (IRB protocol NA\_00004897; Talalay et al. 2007). This investigation will extend the investigators' previous work by employing ionizing rather than ultraviolet radiation. The investigators propose a two part sequential protocol (Study A and Study B). Both studies will involve women with breast cancer who have undergone lumpectomy and are scheduled for adjuvant external beam radiation treatment. In study A, the investigators will validate their technique for measurement of skin erythema using a device called a chromometer; no active agent will be applied (up to 6 women). Study B will follow completion of Study A. Study B will involve the application of broccoli sprout extracts (BSE) or vehicle alone to determine if sulforaphane can reduce radiation-induced erythema (27 women). Four adjacent, 1.5-cm diameter areas-of-interest on the affected breast will be located by means of an adhesive vinyl template which can be accurately and repeatedly placed at the same position. Two of the four areas will be treated with BSE (active agent) and two with vehicle (inactive control). BSE will be applied on three days weekly throughout the 5-week period of whole breast radiation. Erythema will be noninvasively quantified by measuring the red-reflectance of the skin with a chromometer up to three times weekly throughout treatment. A total of 33 patients are to be enrolled. The investigators' ob
Interventions
- OTHER Sulforaphane-containing broccoli sprout extracts (active agent)
- DEVICE Vehicle (inactive control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-04-15 |
| Est. Completion | 2012-11-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00894712
The ClinicalTrials.gov registry entry for NCT00894712 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sulforaphane-containing broccoli sprout extracts (active agent) is the first listed.
NCT00894712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00894712 about?
NCT00894712 is a clinical study titled "Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis". 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 radiation therapy for breast cancer. Topical sulforaphane induces phase 2 enzymes that are protective again...
What is the current status of trial NCT00894712?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2009-04-15. Estimated completion is 2012-11-15.
What interventions are being tested in trial NCT00894712?
The interventions under investigation include: Sulforaphane-containing broccoli sprout extracts (active agent) (OTHER), Vehicle (inactive control) (DEVICE).
Who is sponsoring clinical trial NCT00894712?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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