Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

John Kirkwood

Status and phase: Completed; Early Phase 1

Conditions: Atypical Nevi; Melanoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01568996

10-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

N/A

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 3 patient groups

Low dose BSE-SFN

Experimental group

Description:

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

Treatment:

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

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

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

Mid dose BSE-SFN

Experimental group

Description:

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

Treatment:

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

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

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

High dose BSE-SFN

Experimental group

Description:

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

Treatment:

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

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

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