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| ID | Type | Description | Link |
|---|---|---|---|
| 10-114 | Other Identifier | University of Pittsburgh Cancer Institute (UPCI) |
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This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.
This study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of STAT proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. Eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (BSE-SFN) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. Three groups of six patients will be randomly assigned to receive oral BSE-SFN at SFN dosages of 50 µmol, 100 µmol, or 200 µmol daily. Due to the established safety of SFN at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed SFN dosage levels. However, the safety of BSE-SFN administration will continue to be evaluated through laboratory studies (CBC, chemistry) performed before and following 28 days of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 50 µmol SFN for 28 days. |
|
| Mid dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 100 µmol SFN for 28 days. |
|
| High dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 200 µmol SFN for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| broccoli sprout extract - sulforaphane (BSE-SFN) | Drug | 50 µmol capsules, taken orally, once a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events associated with oral sulforaphane | 2 years | |
| Visual changes of atypical nevi: size, border, color. | 2 years | |
| Cellular changes of the atypical nevi. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sulforaphane levels in the blood as a result of the 3 doses. | 2 years | |
| Effects of sulforaphane on STAT1 and STAT3 expression. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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| Name | Affiliation | Role |
|---|---|---|
| John M Kirkwood, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D004416 | Dysplastic Nevus Syndrome |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| broccoli sprout extract - sulforaphane (BSE-SFN) | Drug | 100 µmol capsules, taken orally, once a day for 28 days |
|
| broccoli sprout extract - sulforaphane (BSE-SFN) | Drug | 200 µmol capsules, taken orally, once a day for 28 days |
|
| D009386 |
| Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |