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Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568996
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):
John Kirkwood, University of Pittsburgh

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01568996

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United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
John Kirkwood
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Principal Investigator: John M Kirkwood, MD University of Pittsburgh
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Responsible Party: John Kirkwood, Professor and Vice Chairman for Clinical Research, University of Pittsburgh Identifier: NCT01568996    
Other Study ID Numbers: 10-114
10-114 ( Other Identifier: University of Pittsburgh Cancer Institute (UPCI) )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by John Kirkwood, University of Pittsburgh:
atypical nevi
Additional relevant MeSH terms:
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Dysplastic Nevus Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents