Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Kirkwood
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Subjects must have at least two atypical nevi of ≥ 4 mm diameter and prior diagnosis of melanoma.

• Subjects must be ≥ age 18.

• Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day 1.

• Subjects should not have known allergies to cruciferous vegetables.

• Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days). Participants will be asked to keep a food diary. A list of food and supplements to abstain from is provided in Appendix A. Patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times.

• Female subjects must not be pregnant or breast feeding within 6 months prior to and during course of study.

• CBC including diff & platelets - without clinically significant abnormalities

• CMP (Na, K, Cl, CO2, glucose, BUN, creatinine, calcium, total protein, albumin, AST, ALT, ALK phos, total bilirubin) - within 2x ULN

Exclusion Criteria:

N/A