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

NCT07040280 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: EA6232HT94252311028
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Keywords

Melanoma; Skin Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months of treatment

Secondary Outcomes (2)

• Change in number of atypical nevi at baseline and after the last treatment be assessed via automated image analysis

  After 12 months of treatment

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Over 12 months

Other Outcomes (4)

• Effects of Sulforaphane on Inflammation and Immunity

  Baseline and 3 months and also baseline and 12 month

• Effects of Sulforaphane on Inflammation and Immunity

  After 12 months

• Effects of Sulforaphane on Inflammation and Immunity

  After 12 months

Study Arms (2)

A

EXPERIMENTAL

Three tablets of Avmacol® Extra Strength \[Nutramax\] by mouth, once daily, for 12 months

Drug: Sulforaphane (broccoli sprout extract); Device: Derma-AI

B

PLACEBO COMPARATOR

Placebo - Three tablets by mouth, once daily, for 12 months

Drug: Placebo; Device: Derma-AI

Interventions

Sulforaphane (broccoli sprout extract) DRUG

Sulforaphane - Three tablets of Avmacol® Extra Strength \[Nutramax\] by mouth, once daily, for 12 months.

Also known as: (Avmacol® Extra Strength)

A

Placebo DRUG

Three tablets by mouth, once daily, for 12 months

B

Derma-AI DEVICE

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

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Kirkwood, MD

  UPMC Hillman Cancer Center

  STUDY CHAIR

Central Study Contacts

John M Kirkwood, MD

CONTACT

412-623-7707; kirkwoodjm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (1)