Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

• ClinicalTrials.gov Identifier: NCT01568996
• Recruitment Status: Completed
• First Posted: April 2, 2012
• Last Update Posted: January 9, 2018
• Sponsor: John Kirkwood
• Information provided by (Responsible Party): John Kirkwood, University of Pittsburgh

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)	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 (Clinical Trial)
• 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: August 2012
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: April 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

Outcome Measures

Primary Outcome Measures :

1. Adverse events associated with oral sulforaphane [ Time Frame: 2 years ]
2. Visual changes of atypical nevi: size, border, color. [ Time Frame: 2 years ]
3. Cellular changes of the atypical nevi. [ Time Frame: 2 years ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

John Kirkwood

Investigators

• Principal Investigator: John M Kirkwood, MD; University of Pittsburgh

More Information

• Responsible Party: John Kirkwood, Professor and Vice Chairman for Clinical Research, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01568996
• Other Study ID Numbers: 10-114; 10-114 ( Other Identifier: University of Pittsburgh Cancer Institute (UPCI) )
• First Posted: April 2, 2012
• Last Update Posted: January 9, 2018
• Last Verified: January 2018

Keywords provided by John Kirkwood, University of Pittsburgh:

atypical nevi; melanoma; sulforaphane; broccoli; lesions; STAT1; STAT3

Additional relevant MeSH terms:

Melanoma; Nevus; Dysplastic Nevus Syndrome; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Sulforaphane; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents