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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252311028 | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Three tablets of Avmacol® Extra Strength [Nutramax] by mouth, once daily, for 12 months |
|
| B | Placebo Comparator | Placebo - Three tablets by mouth, once daily, for 12 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane (broccoli sprout extract) | Drug | Sulforaphane - Three tablets of Avmacol® Extra Strength [Nutramax] by mouth, once daily, for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of atypical nevi at baseline and after the last treatment be assessed via automated image analysis | The number of changed atypical nevi at baseline and after the last treatment (12 months) will be assessed via automated image analysis. The difference in baseline and post-treatment measures will be compared between the two arms using the Wilcoxon rank-sum test. | After 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Sulforaphane on Inflammation and Immunity | Analysis of circulating cytokines, the Wilcoxon signed-rank test will be used to compare the level of each value between timepoints. The Wilcoxon rank-sum test will be used to compare changes in levels between patients receiving sulforaphane and placebo between baseline and 3 months and also baseline and 12 month timepoints. | Baseline and 3 months and also baseline and 12 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M Kirkwood, MD | Contact | 412-623-7707 | kirkwoodjm@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Kirkwood, MD | UPMC Hillman Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| Placebo | Drug | Three tablets by mouth, once daily, for 12 months |
|
| 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 |
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| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Toxicity rate for individual AEs, categorized AEs and worst degree AEs will be compared between the two arms using the Fisher's exact test | Over 12 months |
| Effects of Sulforaphane on Inflammation and Immunity | Pre-post treatment comparisons of mRNA levels normalized to housekeeping genes will be performed using the Wilcoxon signed rank tests. Kruskal-Wallis test will be used to assess differential affects genes grouped into broad pathways as was previously described for sulforaphane | After 12 months |
| Effects of Sulforaphane on Inflammation and Immunity | Dermoscopy and dermoscopic photographs will be performed on the index nevi at each timepoint, and morphologic features will be reported descriptively | After 12 months |
| Effects of Sulforaphane on Inflammation and Immunity | Analysis of the semi-quantitative scoring of immune cell infiltration, the Wilcoxon signed-rank test will be used to compare the level of each value between timepoints. The Wilcoxon rank-sum test will be used to compare changes in levels between patients receiving sulforaphane and placebo between baseline and 3 months and also baseline and 12 month timepoints. | Baseline and 3 months and also baseline and 12 month |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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