Clinical trial · Interventional
Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
NCT01568996CI-TRIAL-00031106completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Nevi | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| broccoli sprout extract - sulforaphane (BSE-SFN) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low dose BSE-SFN
- description
- BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
- interventionNames
- Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
- type
- EXPERIMENTAL
- label
- Mid dose BSE-SFN
- description
- BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
- interventionNames
- Drug: broccoli sprout extract - sulforaphane (BSE-SFN)
- type
- EXPERIMENTAL
- label
- High dose BSE-SFN
- description
- BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.