About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sulforaphane (broccoli sprout extract)
- Placebo
- Derma-AI
Treatment groups
Sponsors and collaborators
Eastern Cooperative Oncology Group
Lead sponsor
National Institutes of Health (NIH)
Collaborator