Clinical Trial: Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma

Brief Summary: This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.

Detailed Summary: This study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of STAT proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. Eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (BSE-SFN) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. Three groups of six patients will be randomly assigned to receive oral BSE-SFN at SFN dosages of 50 µmol, 100 µmol, or 200 µmol daily. Due to the established safety of SFN at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed SFN dosage levels. However, the safety of BSE-SFN administration will continue to be evaluated through laboratory studies (CBC, chemistry) performed before and following 28 days of administration.
Sponsor: John Kirkwood

Current Primary Outcome:

  • Adverse events associated with oral sulforaphane [ Time Frame: 2 years ]
  • Visual changes of atypical nevi: size, border, color. [ Time Frame: 2 years ]
  • Cellular changes of the atypical nevi. [ Time Frame: 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sulforaphane levels in the blood as a result of the 3 doses. [ Time Frame: 2 years ]
  • Effects of sulforaphane on STAT1 and STAT3 expression. [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: March 29, 2012
Date Started: August 2012
Date Completion: November 2017
Last Updated: January 18, 2017
Last Verified: January 2017