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NCT00894712

Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis

Completed Last updated 7 May 2019
What this trial tests

trial testing Sulforaphane-containing broccoli sprout extracts (active agent) in Breast Cancer in 12 participants. Completed in 15 November 2012.

Timeline
15 April 2009
Primary endpoint
15 November 2012
15 November 2012

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
StatusCompleted
Study typeOBSERVATIONAL
Enrollment12
Start date15 April 2009
Primary completion15 November 2012
Estimated completion15 November 2012
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, female only, with Breast Cancer or Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dietary Sulforaphane in Cancer Chemoprevention: The Role of Epigenetic Regulation and HDAC Inhibition.
    Tortorella SM, Royce SG, Licciardi PV, Karagiannis TC. · · 2015 · cited 131× · PMID 25364882 · DOI 10.1089/ars.2014.6097
  2. Role of dietary bioactive natural products in estrogen receptor-positive breast cancer.
    Bak MJ, Das Gupta S, Wahler J, Suh N. · · 2016 · cited 56× · PMID 27016037 · DOI 10.1016/j.semcancer.2016.03.001
  3. Predictive biomarkers and potential drug combinations of epi-drugs in cancer therapy.
    Yang T, Yang Y, Wang Y. · · 2021 · cited 28× · PMID 34001246 · DOI 10.1186/s13148-021-01098-2

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