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Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

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

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 2, 2012
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • Adverse events associated with oral sulforaphane [ Time Frame: 2 years ]
  • Visual changes of atypical nevi: size, border, color. [ Time Frame: 2 years ]
  • Cellular changes of the atypical nevi. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • Sulforaphane levels in the blood as a result of the 3 doses. [ Time Frame: 2 years ]
  • Effects of sulforaphane on STAT1 and STAT3 expression. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
Official Title  ICMJE A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atypical Nevi
  • Melanoma
Intervention  ICMJE
  • Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
    50 µmol capsules, taken orally, once a day for 28 days
  • Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
    100 µmol capsules, taken orally, once a day for 28 days
  • Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
    200 µmol capsules, taken orally, once a day for 28 days
Study Arms  ICMJE
  • Experimental: Low dose BSE-SFN
    BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
    Intervention: Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
  • Experimental: Mid dose BSE-SFN
    BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
    Intervention: Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
  • Experimental: High dose BSE-SFN
    BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
    Intervention: Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2012)
18
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01568996
Other Study ID Numbers  ICMJE 10-114
10-114 ( Other Identifier: University of Pittsburgh Cancer Institute (UPCI) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Kirkwood, University of Pittsburgh
Study Sponsor  ICMJE John Kirkwood
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John M Kirkwood, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP