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: November 7, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Dermatitis
Other: Sulforaphane-containing broccoli sprout extracts (active agent)
Device: Vehicle (inactive control)
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Clinical grade of dermatitis (per NCI CTCAE v3.0 guidelines) for each region. [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2009
Estimated Study Completion Date: April 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast Cancer

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00894712

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Richard Zellars, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00894712     History of Changes
Other Study ID Numbers: J-0838, NA_00018779
Study First Received: May 5, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Radiation Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014