The goal of this clinical trial is to compare the safety and effects of sulforaphane with the safety and effects of placebo on people's risk of developing melanoma. The main question it aims to answer is:
Will giving sulforaphane (a broccoli sprout extract) have a meaningful effect on how your atypical moles change over time? If there is an effect, will this lower your risk of developing melanoma?
Participants will:
Take sulforaphane or a placebo for 12 months Visit the clinic once every 3 months for checkups and tests You will keep a calendar which will help you keep track of when you take your tablets
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.27
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
Patient must not be pregnant.
Patient must not have a known allergy to cruciferous vegetables.
Patients must not use any other sulforaphane-containing dietary supplement during the study period.
Patient must not be on any current systemic treatment for melanoma.
Parallel
Sulforaphane (broccoli sprout extract)
DrugSulforaphane - Three tablets of Avmacol® Extra Strength \[Nutramax\] by mouth, once daily, for 12 months.
Placebo
DrugThree tablets by mouth, once daily, for 12 months
Derma-AI
DevicePhotographs of lesions as part of the clinical exam at baseline, three (3) months, and twelve (12) months. These photographs will be submitted for assessment by a software called Derma-AI, which tracks moles over time for changes in size, number, and appearance
Changes in the total area of nevi after 12 months of treatment from the baseline between sulforaphane and placebo arms
The change in the total area of atypical and common pigmented nevocellular nevi measured at baseline and after 12 months of treatment, will be assessed in each patient who completed the full 12 months of treatment (with compliance assessed by dosing logs). The difference in the change of total area of nevi between the two arms will be compared using the Wilcoxon rank sum test.
Change in number of atypical nevi at baseline and after the last treatment be assessed via automated image analysis
The number of changed atypical nevi at baseline and after the last treatment (12 months) 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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Toxicity rate for individual AEs, categorized AEs and worst degree AEs will be compared between the two arms using the Fisher's exact test
Effects of Sulforaphane on Inflammation and Immunity
Analysis of circulating cytokines, the Wilcoxon signed-rank 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 between baseline and 3 months and also baseline and 12 month timepoints.
Effects of Sulforaphane on Inflammation and Immunity
Pre-post treatment comparisons of mRNA levels normalized to housekeeping genes will be performed using the Wilcoxon signed rank tests. Kruskal-Wallis test will be used to assess differential affects genes grouped into broad pathways as was previously described for sulforaphane
Effects of Sulforaphane on Inflammation and Immunity
Dermoscopy and dermoscopic photographs will be performed on the index nevi at each timepoint, and morphologic features will be reported descriptively
Effects of Sulforaphane on Inflammation and Immunity
Analysis of the semi-quantitative scoring of immune cell infiltration, the Wilcoxon signed-rank 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 between baseline and 3 months and also baseline and 12 month timepoints.
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Eastern Cooperative Oncology Group
Lead sponsor
National Institutes of Health (NIH)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
