Atypical NeviEarly Phase 1NCT01568996
Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
A Early Phase 1 study testing broccoli sprout extract - sulforaphane (BSE-SFN) in people with Atypical Nevi and Melanoma, run by John Kirkwood at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atypical Nevi, Melanoma
- What is being tested?
- broccoli sprout extract - sulforaphane (BSE-SFN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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.
Read the 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.
- Conditions
- Atypical Nevi, Melanoma
- Being tested
- broccoli sprout extract - sulforaphane (BSE-SFN)
- Keywords
- atypical nevi, melanoma, sulforaphane, broccoli, lesions, STAT1, STAT3
- Medical subject headings
- Dysplastic Nevus Syndrome, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
broccoli sprout extract - sulforaphane (BSE-SFN)Drug
50 µmol capsules, taken orally, once a day for 28 days
broccoli sprout extract - sulforaphane (BSE-SFN)Drug
100 µmol capsules, taken orally, once a day for 28 days
broccoli sprout extract - sulforaphane (BSE-SFN)Drug
200 µmol capsules, taken orally, once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Low dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 50 µmol SFN for 28 days. Receives: Drug: broccoli sprout extract - sulforaphane (BSE-SFN) |
| Mid dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 100 µmol SFN for 28 days. Receives: Drug: broccoli sprout extract - sulforaphane (BSE-SFN) |
| High dose BSE-SFN | Experimental | BSE-SFN will be orally administered at 200 µmol SFN for 28 days. Receives: Drug: broccoli sprout extract - sulforaphane (BSE-SFN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events associated with oral sulforaphane
Measured: 2 years
Visual changes of atypical nevi: size, border, color.
Measured: 2 years
Cellular changes of the atypical nevi.
Measured: 2 years
Secondary outcomes (2)
Sulforaphane levels in the blood as a result of the 3 doses.
Measured: 2 years
Effects of sulforaphane on STAT1 and STAT3 expression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical NeviStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Kirkwood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Kirkwood, University of Pittsburgh
- Investigators
- John M Kirkwood, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568996
- Sponsor's protocol ID
- 10-114
- Other IDs
- 10-114
- Status last verified
- Jan 2018
- First submitted
- 29 Mar 2012
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
- ClinicalTrials.gov ID
- NCT01568996
- Acronym / sponsor ID
- 10-114
- Conditions
- Atypical Nevi, Melanoma
- Keywords
- atypical nevi, melanoma, sulforaphane, broccoli, lesions, STAT1, STAT3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- John KirkwoodUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose BSE-SFN | Experimental | Drug: broccoli sprout extract - sulforaphane (BSE-SFN)BSE-SFN will be orally administered at 50 µmol SFN for 28 days. |
| Mid dose BSE-SFN | Experimental | Drug: broccoli sprout extract - sulforaphane (BSE-SFN)BSE-SFN will be orally administered at 100 µmol SFN for 28 days. |
| High dose BSE-SFN | Experimental | Drug: broccoli sprout extract - sulforaphane (BSE-SFN)BSE-SFN will be orally administered at 200 µmol SFN for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| broccoli sprout extract - sulforaphane (BSE-SFN)50 µmol capsules, taken orally, once a day for 28 days | Drug | Low dose BSE-SFN |
| broccoli sprout extract - sulforaphane (BSE-SFN)100 µmol capsules, taken orally, once a day for 28 days | Drug | Mid dose BSE-SFN |
| broccoli sprout extract - sulforaphane (BSE-SFN)200 µmol capsules, taken orally, once a day for 28 days | Drug | High dose BSE-SFN |
Primary outcome
Adverse events associated with oral sulforaphane
Time frame: 2 years
Visual changes of atypical nevi: size, border, color.
Time frame: 2 years
Cellular changes of the atypical nevi.
Time frame: 2 years
2 secondary outcomes
Sulforaphane levels in the blood as a result of the 3 doses.
Time frame: 2 years
Effects of sulforaphane on STAT1 and STAT3 expression.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
Related trials for Atypical Nevi
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
RecruitingObservational study
Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome
Uveal Melanoma, Cutaneous Melanoma
RecruitingPhase 2
A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information
Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8
RecruitingPhase 2
Sulforaphane for the Prevention of Melanoma in Patients With Multiple Atypical Nevi and a Prior History of Melanoma
Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Kirkwood, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing broccoli sprout extract - sulforaphane (BSE-SFN) in people with Atypical Nevi and Melanoma, run by John Kirkwood at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events associated with oral sulforaphane (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.