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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00894712
First received: May 5, 2009
Last updated: October 2, 2014
Last verified: October 2014

May 5, 2009
October 2, 2014
April 2009
November 2012   (final data collection date for primary outcome measure)
  • Variance of the skin erythema measurements due to non-radiation effects. [ Time Frame: Week 0 and Week 1 of radiation treatment ] [ Designated as safety issue: No ]
  • Absolute change in red reflectance of the skin. [ Time Frame: before and after radiation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00894712 on ClinicalTrials.gov Archive Site
Clinical grade of dermatitis (per NCI CTCAE v3.0 guidelines) for each region. [ Time Frame: weekly ] [ Designated as safety issue: No ]
Same as current
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Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis
Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Breast Cancer

  • Breast Cancer
  • Dermatitis
  • Other: Sulforaphane-containing broccoli sprout extracts (active agent)
    Topical application, prepared with acetone, 280 nml daily, 3 times a week.
  • Device: Vehicle (inactive control)
    Subjects will have measurements of skin erythema using a device called a chromometer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
November 2015
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00894712
J-0838, NA_00018779
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Richard Zellars, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP