NCT01568996

Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: John Kirkwood · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atypical Nevi
• Melanoma

Interventions

Type	Name	Description
DRUG	broccoli sprout extract - sulforaphane (BSE-SFN)	50 µmol capsules, taken orally, once a day for 28 days
DRUG	broccoli sprout extract - sulforaphane (BSE-SFN)	100 µmol capsules, taken orally, once a day for 28 days
DRUG	broccoli sprout extract - sulforaphane (BSE-SFN)	200 µmol capsules, taken orally, once a day for 28 days

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2012-04-02
• Last updated: 2018-01-09

Locations

1 site across 1 country: United States