Sulforaphane for Skin Cancer

Overseen By John M Kirkwood, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eastern Cooperative Oncology Group

Must not be taking: Targeted, Checkpoint immunotherapy

Disqualifiers: Pregnancy, Cruciferous allergy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sulforaphane, a broccoli sprout extract, can reduce melanoma risk by affecting atypical moles. Participants will take either sulforaphane or a placebo for 12 months to determine if their moles change meaningfully. It suits individuals with at least three unusual moles and a history of early-stage melanoma. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any systemic treatment for melanoma or use other sulforaphane supplements during the study.

Is there any evidence suggesting that sulforaphane is likely to be safe for humans?

Research has shown that sulforaphane, a compound in broccoli sprouts, is generally safe for use. It has been safely used in humans for up to six months. Studies indicate that daily intake of sulforaphane is well-tolerated, and it is often consumed in natural forms, like vegetables, without major side effects.

Sulforaphane has been studied in other trials for its effects on various cancers and conditions. It has shown potential in protecting the skin from sun damage and reducing tumor growth. While these studies suggest that sulforaphane is safe, this trial will provide more information about its safety over a longer period of 12 months. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Researchers are excited about sulforaphane for skin cancer because it offers a new, natural approach compared to traditional treatments like surgery, topical therapies, or chemotherapy. Sulforaphane is derived from cruciferous vegetables like broccoli, and it works by enhancing the body’s ability to detoxify carcinogens. This unique mechanism may help in preventing cancer cell growth, making it a promising addition to current skin cancer treatment options. Unlike some existing treatments that can have harsh side effects, sulforaphane is generally well-tolerated, which could improve patient experience.

What evidence suggests that sulforaphane might be an effective treatment for skin cancer?

Research has shown that sulforaphane, a compound in broccoli sprouts, can protect skin from UV damage and may slow tumor growth. Studies have found that this extract disrupts the growth and spread of cancer cells. Some evidence suggests that sulforaphane enhances the effectiveness of existing cancer treatments by targeting several cancer-related pathways. These effects make sulforaphane a promising option for reducing melanoma risk, particularly by affecting unusual moles. Although more research is needed, these early findings offer hope for its role in preventing skin cancer. Participants in this trial will receive either sulforaphane in the form of Avmacol® Extra Strength or a placebo to evaluate its effectiveness over 12 months. ^{3 6 7 8 9}

Who Is on the Research Team?

John Kirkwood, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have had melanoma in the past and are at risk of it returning. Participants will take sulforaphane or a placebo for a year, with clinic visits every three months. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

Must have at least two of the following features: ill-defined borders, color variegation, uneven contour, and erythema

I can understand and am willing to sign the consent form.

I was previously diagnosed with early-stage melanoma.

Exclusion Criteria

Patient must not be pregnant

Patient must not have a known allergy to cruciferous vegetables

I am not taking any sulforaphane supplements during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take sulforaphane or a placebo for 12 months

12 months

Visit the clinic once every 3 months for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sulforaphane

Trial Overview

The trial tests if sulforaphane, found in broccoli sprouts, can prevent melanoma recurrence compared to a placebo. It monitors changes in atypical moles over time to assess effectiveness.

How Is the Trial Designed?

Group I: A Experimental Treatment 2 Interventions

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

Group II: B Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07040280

Testing the Effect of Sulforaphane, a Compound Naturally ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6030491/

Evaluation of biodistribution of sulforaphane after ...

Broccoli sprout extract containing sulforaphane (BSE-SFN) has been shown to inhibit ultraviolet radiation-induced damage and tumor progression in skin.

3.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06404

Evaluation of Broccoli Seed and Sprout Extract for ...

This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol ...

4.

withpower.com

withpower.com/trial/phase-2-melanoma-9-2025-68df3

Sulforaphane for Skin Cancer · Info for Participants

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211715625000426

Sulforaphane in alternative cancer chemotherapy

In conclusion, SFN shows significant promise in cancer therapy by targeting multiple molecular pathways, improving the efficacy of chemotherapy, and overcoming ...

6.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More

It is possibly safe when used as medicine. Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/74/NCT05153174/Prot_SAP_000.pdf

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ...

SFN is currently in clinical trials for cancer of the breast, lung, and prostate, as well as autism and schizophrenia, and cardiotoxicity from chemotherapy ( ...

8.

longevity.technology

longevity.technology/clinics/are-there-any-dangerous-side-effects-of-sulforaphane/

Are There Any Dangerous Side Effects of Sulforaphane?

Taking sulforaphane daily is generally considered safe, especially when consumed through natural dietary sources like cruciferous vegetables.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0944711324003908

Protective effects of sulforaphane against toxic substances ...

SFN exerts its protective effects by activating the Nrf2 pathway, which enhances antioxidant defenses and reduces oxidative stress.