Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

Sponsor

John Kirkwood (Other)

Overall Status

Completed

CT.gov ID

NCT01568996

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atypical Nevi Melanoma	Drug: broccoli sprout extract - sulforaphane (BSE-SFN) Drug: broccoli sprout extract - sulforaphane (BSE-SFN) Drug: broccoli sprout extract - sulforaphane (BSE-SFN)	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose BSE-SFN BSE-SFN will be orally administered at 50 µmol SFN for 28 days.	Drug: broccoli sprout extract - sulforaphane (BSE-SFN) 50 µmol capsules, taken orally, once a day for 28 days
Experimental: Mid dose BSE-SFN BSE-SFN will be orally administered at 100 µmol SFN for 28 days.	Drug: broccoli sprout extract - sulforaphane (BSE-SFN) 100 µmol capsules, taken orally, once a day for 28 days
Experimental: High dose BSE-SFN BSE-SFN will be orally administered at 200 µmol SFN for 28 days.	Drug: broccoli sprout extract - sulforaphane (BSE-SFN) 200 µmol capsules, taken orally, once a day for 28 days

Arm

Intervention/Treatment

Experimental: Low dose BSE-SFN

BSE-SFN will be orally administered at 50 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

50 µmol capsules, taken orally, once a day for 28 days

Experimental: Mid dose BSE-SFN

BSE-SFN will be orally administered at 100 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

100 µmol capsules, taken orally, once a day for 28 days

Experimental: High dose BSE-SFN

BSE-SFN will be orally administered at 200 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

200 µmol capsules, taken orally, once a day for 28 days

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Sulforaphane levels in the blood as a result of the 3 doses. [2 years]
Effects of sulforaphane on STAT1 and STAT3 expression. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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