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 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' objective is to determine and quantify the effect of topical BSE on
radiation-induced skin erythema. This study will employ standard, clinically-accepted
radiation doses and techniques that are safe and well tolerated. The safety and
tolerability of both oral and topical broccoli sprout preparations is well established; no
safety concerns have been noted. (Shapiro et al. 2006; Dinkova-Kostova et al. 2007).