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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
Sulforaphane - Three tablets of Avmacol® Extra Strength \[Nutramax\] by mouth, once daily, for 12 months.
Three tablets by mouth, once daily, for 12 months
Photographs 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
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
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.
Time frame: 12 months of treatment
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.
Time frame: After 12 months of treatment
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
Time frame: Over 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.