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Sulforaphane for Preventing Melanoma in Patients with Prior Melanoma

This study is testing if sulforaphane (a compound found naturally in broccoli sprouts) can help prevent melanoma in people who have had melanoma before. You would take either sulforaphane or a placebo (an inactive pill) once a day for 12 months. Researchers want to see if sulforaphane changes how your atypical moles (moles that look unusual) develop over time, which could lower your risk of getting melanoma. To join, you must be at least 18 years old and have at least three atypical moles that meet specific size and appearance requirements. The study is currently unclear about its recruitment status and aims to enroll 120 participants.

Study design
This interventional study plans to enroll 120 participants. It compares sulforaphane to a placebo to see their effects on melanoma prevention.
What's involved
You would take three tablets daily for 12 months and visit the clinic every three months for checkups and tests. You will also keep a calendar to track your tablet intake.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in moles after 12 months of treatment, indicating follow-up during this period.

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NCT07040280

Testing the Effect of Sulforaphane, a Compound Naturally Found in Cruciferous Vegetables, on Preventing Melanoma in Patients With a Prior History of Melanoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalPrevention
Eastern Cooperative Oncology Group
~120 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:Sulforaphane (broccoli sprout extract)PlaceboDerma-AI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in the total area of nevi after 12 months of treatment from the baseline between sulforaphane and placebo arms
Measured over 12 months of treatment

Conditions

Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • John Kirkwood, MD · STUDY_CHAIR · UPMC Hillman Cancer Center

Who to contact

John M Kirkwood, MD
[email protected]
412-623-7707
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 have a prior diagnosis of early-stage melanoma, defined as either melanoma in situ, localized resected stage I-II node negative melanoma, or resected node positive stage III melanoma who in the assessment of their physician have a low risk of relapse of their prior melanoma within one year of randomization.
Patient must not be currently on targeted or checkpoint immunotherapy or treated within 365 days prior to randomization.
Patient must be ≥ 18 years of age.
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Patients with a prior or concurrent malignancy (other than the melanoma for which they are on this study), whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, are eligible for this trial.

Exclusion

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.

What this trial measures

  • Changes in the total area of nevi after 12 months of treatment from the baseline between sulforaphane and placebo arms12 months of treatment

    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.