Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
John Kirkwood, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01568996
First received: March 29, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Atypical Nevi
Melanoma
Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Adverse events associated with oral sulforaphane [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Visual changes of atypical nevi: size, border, color. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cellular changes of the atypical nevi. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sulforaphane levels in the blood as a result of the 3 doses. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effects of sulforaphane on STAT1 and STAT3 expression. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568996

Contacts
Contact: John M Kirkwood, MD 412-623-7707 kirkwoodjm@upmc.edu
Contact: Carrie Muniz, RN, BSN (412) 623-6121 munizca@upmc.edu

Locations
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
John Kirkwood
Investigators
Principal Investigator: John M Kirkwood, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: John Kirkwood, Professor and Vice Chairman for Clinical Research, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01568996     History of Changes
Other Study ID Numbers: 10-114, 10-114
Study First Received: March 29, 2012
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
atypical nevi
melanoma
sulforaphane
broccoli
lesions
STAT1
STAT3

Additional relevant MeSH terms:
Melanoma
Nevus
Nevus, Pigmented
Dysplastic Nevus Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014