Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

NCT ID: NCT01568996

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low dose BSE-SFN

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

Group Type: EXPERIMENTAL

broccoli sprout extract - sulforaphane (BSE-SFN)

Intervention Type: DRUG

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

Mid dose BSE-SFN

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

Group Type: EXPERIMENTAL

broccoli sprout extract - sulforaphane (BSE-SFN)

Intervention Type: DRUG

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

High dose BSE-SFN

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

Group Type: EXPERIMENTAL

broccoli sprout extract - sulforaphane (BSE-SFN)

Intervention Type: DRUG

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

Interventions

broccoli sprout extract - sulforaphane (BSE-SFN)

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

Intervention Type: DRUG

broccoli sprout extract - sulforaphane (BSE-SFN)

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

Intervention Type: DRUG

broccoli sprout extract - sulforaphane (BSE-SFN)

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Kirkwood

OTHER

Sponsor Role: lead

Responsible Party

John Kirkwood

Professor and Vice Chairman for Clinical Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John M Kirkwood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

10-114

Identifier Type: OTHER

Identifier Source: secondary_id

10-114

Identifier Type: -

Identifier Source: org_study_id