Finding studies
Finding studies
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Lead
ECOG-ACRIN Cancer Research Group
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
