Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568996
• Other study ID #: 10-114
• Secondary ID: 10-114
• Status: Completed
• Phase: Early Phase 1
• First received: March 29, 2012
• Last updated: January 7, 2018
• Start date: August 2012
• Est. completion date: April 2016

Study information

• Verified date: January 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Atypical Nevi
• Dysplastic Nevus Syndrome
• Melanoma
• Nevus

Intervention

Drug:
• broccoli sprout extract - sulforaphane (BSE-SFN)
50 µmol capsules, taken orally, once a day for 28 days
• broccoli sprout extract - sulforaphane (BSE-SFN)
100 µmol capsules, taken orally, once a day for 28 days
• broccoli sprout extract - sulforaphane (BSE-SFN)
200 µmol capsules, taken orally, once a day for 28 days

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
John Kirkwood

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events associated with oral sulforaphane		2 years
Primary	Visual changes of atypical nevi: size, border, color.		2 years
Primary	Cellular changes of the atypical nevi.		2 years
Secondary	Sulforaphane levels in the blood as a result of the 3 doses.		2 years
Secondary	Effects of sulforaphane on STAT1 and STAT3 expression.		2 years