Testing the Effect of Sulforaphane, a Compound Naturally Found in Cruciferous Vegetables, on Preventing Melanoma in Patients With a Prior History of Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sulforaphane (broccoli sprout extract), Placebo, Derma-AI.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Double-Blind Trial of Sulforaphane for Therapeutic Prevention of Melanoma in Patients With Multiple Atypical Nevi and a Prior History of Melanoma
Overview
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
Interventions
- Drug Sulforaphane (broccoli sprout extract)
Sulforaphane - Three tablets of Avmacol® Extra Strength \[Nutramax\] by mouth, once daily, for 12 months. - Drug Placebo
Three tablets by mouth, once daily, for 12 months - Device Derma-AI
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
Primary outcome measures
- Changes in the total area of nevi after 12 months of treatment from the baseline between sulforaphane and placebo arms [Time frame: 12 months of treatment]
Secondary outcome measures (2)
- Change in number of atypical nevi at baseline and after the last treatment be assessed via automated image analysis [Time frame: After 12 months of treatment]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Over 12 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UPMC Hillman Cancer Center — Pittsburgh
Identifiers
NCT: NCT07040280 · EA6232 · HT94252311028