Back to resultsPilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
Primary Purpose
Atypical Nevi, Melanoma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
broccoli sprout extract - sulforaphane (BSE-SFN)
broccoli sprout extract - sulforaphane (BSE-SFN)
broccoli sprout extract - sulforaphane (BSE-SFN)
Sponsored by
About this trial
This is an interventional prevention trial for Atypical Nevi focused on measuring atypical nevi, melanoma, sulforaphane, broccoli, lesions, STAT1, STAT3
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
Sites / Locations
- UPMC Hillman Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low dose BSE-SFN
Mid dose BSE-SFN
High dose BSE-SFN
Arm Description
BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
Outcomes
Primary Outcome Measures
Adverse events associated with oral sulforaphane
Visual changes of atypical nevi: size, border, color.
Cellular changes of the atypical nevi.
Secondary Outcome Measures
Sulforaphane levels in the blood as a result of the 3 doses.
Effects of sulforaphane on STAT1 and STAT3 expression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568996
Brief Title
Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
Official Title
A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Kirkwood
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Nevi, Melanoma
Keywords
atypical nevi, melanoma, sulforaphane, broccoli, lesions, STAT1, STAT3
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose BSE-SFN
Arm Type
Experimental
Arm Description
BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
Arm Title
Mid dose BSE-SFN
Arm Type
Experimental
Arm Description
BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
Arm Title
High dose BSE-SFN
Arm Type
Experimental
Arm Description
BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
Intervention Type
Drug
Intervention Name(s)
broccoli sprout extract - sulforaphane (BSE-SFN)
Intervention Description
50 µmol capsules, taken orally, once a day for 28 days
Intervention Type
Drug
Intervention Name(s)
broccoli sprout extract - sulforaphane (BSE-SFN)
Intervention Description
100 µmol capsules, taken orally, once a day for 28 days
Intervention Type
Drug
Intervention Name(s)
broccoli sprout extract - sulforaphane (BSE-SFN)
Intervention Description
200 µmol capsules, taken orally, once a day for 28 days
Primary Outcome Measure Information:
Title
Adverse events associated with oral sulforaphane
Time Frame
2 years
Title
Visual changes of atypical nevi: size, border, color.
Time Frame
2 years
Title
Cellular changes of the atypical nevi.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Sulforaphane levels in the blood as a result of the 3 doses.
Time Frame
2 years
Title
Effects of sulforaphane on STAT1 and STAT3 expression.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Kirkwood, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
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Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
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