This phase II trial tests how well sulforaphane works in preventing melanoma in patients with multiple atypical moles (nevi) and a prior history of melanoma. Patients with a history of melanoma and multiple atypical nevi are at a significantly increased risk of developing additional melanomas than those without atypical nevi. Prevention measures usually include sun protection, monthly skin self-examinations and regular skin examinations from a doctor. Sulforaphane is a naturally-occurring substance found in many cruciferous vegetables, including broccoli, that may prevent melanoma from forming.
Patient must have ≥ 3 clinically atypical nevi, assessed within 30 days prior to randomization, that are consistent with the International Agency for Research on Cancer (IARC) definition as follows.
Must have a diameter of ≥ 5mm in one dimension
Must include a macular component in at least one area
Must have at least two of the following features: ill-defined borders, color variegation, uneven contour, and erythema NOTE: Lesions suspicious for incipient melanoma will be removed and are not intended for the study
None
Parallel
Biopsy Procedure
Procedure/SurgeryUndergo optional excisional biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Placebo Administration
DrugGiven PO
Sulforaphane
DrugGiven PO
Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk
Changes in the total area of nevi compared between the arms will be assessed by Derma-AI digital photographic imaging and analysis using image analysis software. The difference in the change of total area of nevi between the two arms will be compared using the Wilcoxon rank sum test.
Number of changed atypical nevi on the posterior trunk
The number of changed atypical nevi will be assessed via automated image analysis. The difference in baseline and post-treatment measures will be compared between the two arms using the Wilcoxon rank-sum test. Both intent-to-treat and per-protocol analyses will be conducted.
Incidence of adverse events (AEs)
Incidence of AEs assessed per Common Terminology Criteria for Adverse Events as well as by dosing deviations. Toxicity rate for individual AEs, categorized AEs and worst degree AEs will be compared between the two arms using the Fisher's exact test.
Circulating serum cytokine and chemokine levels
Assessed by multiplex technology. The Wilcoxon rank-sum test will be used to compare the level of each value between timepoints. The Wilcoxon rank-sum test will be used to compare changes in levels between patients receiving sulforaphane and placebo.
Immune cell infiltration
Assessed by traditional histopathology and immunohistochemistry. Traditional histopathologic features of nevi will be reported descriptively. The Wilcoxon rank-sum test will be used to compare changes in levels between patients.
Dermoscopic features of the atypical nevi
Dermoscopy and dermoscopic photographs will be performed on the index nevi at each timepoint, and morphologic features will be reported descriptively.
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