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.
PRIMARY OBJECTIVE: I. To evaluate the effects of oral sulforaphane versus (vs) placebo on change in the total area of atypical and common pigmented nevocellular nevi on the posterior trunk at 12 months after randomization as assessed by digital photographic imaging and analysis using Derma-AI image analysis software, specifically assessed in patients treated for the entire 12-month treatment period (per-protocol analysis). SECONDARY OBJECTIVES: I. To evaluate the effects of oral sulforaphane vs placebo on the number of atypical and common pigmented nevocellular nevi with moderate and significant changes in area on the posterior trunk at 12 months after randomization as assessed by digital photographic imaging and analysis using Derma-AI image analysis software, specifically assessed in patients treated for the entire 12-month treatment period (Intent-to-Treat \[ITT\] analysis). II. To determine the effects of 12 months of sulforaphane treatment versus vs placebo on the total area and features of atypical nevi at 12 months, assessed as above in all randomized patients. III. To assess the safety/tolerability of sulforaphane (three Avmacol® Extra Strength \[Nutramax\] tablets once daily over 12 months), assessed per Common Terminology Criteria for Adverse Events (CTCAE), as well as by dosing deviations among all treated patients. EXPLORATORY OBJECTIVES: I. Effects of sulforaphane on inflammation and immunity: Ia. To evaluate the effects of sulforaphane on circulating serum cytokine and chemokine levels, as assessed by multiplex technology (Luminex or similar); Ib. To evaluate the effects of sulforaphane on immune cell infiltration in atypical melanocytic nevocellular nevi, as assessed by traditional histopathology and immunohistochemistry. III. To evaluate dermoscopic features of targeted prespecified atypical melanocytic nevocellular nevi at each timepoint. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive sulforaphane orally (PO) twice daily (BID) for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study. ARM B: Patients receive placebo PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study. After completion of study treatment, patients are followed every 3 months for 24 months from randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
Undergo optional excisional biopsy
Undergo blood sample collection
Given PO
Given PO
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGChange 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.
Time frame: From baseline to 12 months after randomization
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.
Time frame: At baseline and 12 months after randomization
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.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.