Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

January 7, 2018 updated by: John Kirkwood

A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

17

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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
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)
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
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events associated with oral sulforaphane
Time Frame: 2 years
2 years
Visual changes of atypical nevi: size, border, color.
Time Frame: 2 years
2 years
Cellular changes of the atypical nevi.
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Kirkwood

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-114 (University of Pittsburgh Cancer Institute (UPCI))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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