Broccoli Sprout Extract for Melanoma Prevention in People With a History of Melanoma and Atypical Moles

About the Study

People who have previously had melanoma and multiple atypical moles may have an increased risk of developing another melanoma. Sulforaphane is a naturally occurring compound found in cruciferous vegetables, including broccoli. Laboratory research suggests that sulforaphane may have effects on cells that could help prevent cancer from developing.

This clinical trial is studying whether taking a sulforaphane supplement for 12 months affects the appearance and number of atypical moles in people who have previously had early-stage melanoma. Researchers will also check whether the supplement is safe and well-tolerated. The study compares sulforaphane with a placebo (a pill that looks like the study supplement but contains no active ingredient).

What the Study Involves

Participants will be randomly assigned to one of two groups:

• Group 1: Take a sulforaphane supplement by mouth twice daily for up to 12 months.

• Group 2: Take a placebo by mouth twice daily for up to 12 months.

Participants will not know which group they are assigned to. The researchers and study team will also not know which participants are receiving sulforaphane or the placebo.

Participants will have skin examinations and photographs taken to document the appearance and number of atypical moles. Photographs will be taken at the beginning of the study, at 3 months, and at 12 months. Specialized software will analyze the photographs to measure changes in the moles over time.

Blood samples will also be collected during the study. Researchers may also perform optional biopsies (removal of a small amount of tissue for examination) of atypical moles.

Participants will take their assigned supplement for up to 12 months, unless side effects prevent them from continuing. After completing the study treatment, participants will have follow-up visits every three months for another 24 months.

Adults aged 18 and older who meet all of the following criteria:

• Have a history of early-stage melanoma that has been treated, including melanoma in situ, stage 1 or 2 melanoma that has been surgically removed without lymph node involvement, or certain stage 3 melanomas that have been surgically removed.
• Have at least three atypical moles that meet specific criteria based on their size and appearance.
• Have not received targeted therapy or immunotherapy for melanoma within the past year.
• Are not currently receiving systemic treatment for melanoma.

People who:

• Are under age 18.
• Have an allergy to broccoli or other cruciferous vegetables.
• Are currently taking another sulforaphane-containing dietary supplement.
• Are pregnant or unable to meet the study's pregnancy-prevention requirements, if applicable.
• Are currently receiving systemic treatment for melanoma.
• Are currently receiving targeted therapy or immunotherapy for melanoma or have received either treatment within the past year.