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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07040280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eastern Cooperative Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John Kirkwood, MD
Principal Investigator Affiliation UPMC Hillman Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Experimental: A

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

Placebo Comparator: B

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania

Status

Address

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213

Site Contact

John Kirkwood, MD

[email protected]

412-623-7707

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