A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Adverse events associated with oral sulforaphane
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have at least two atypical nevi of ≥ 4 mm diameter and prior diagnosis of melanoma.
- •Subjects must be ≥ age
- •Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day
- •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
排除标准
- 未提供
研究组 & 干预措施
Low dose BSE-SFN
BSE-SFN will be orally administered at 50 µmol SFN for 28 days.
干预措施: broccoli sprout extract - sulforaphane (BSE-SFN) (Drug)
Mid dose BSE-SFN
BSE-SFN will be orally administered at 100 µmol SFN for 28 days.
干预措施: broccoli sprout extract - sulforaphane (BSE-SFN) (Drug)
High dose BSE-SFN
BSE-SFN will be orally administered at 200 µmol SFN for 28 days.
干预措施: broccoli sprout extract - sulforaphane (BSE-SFN) (Drug)
结局指标
主要结局
Adverse events associated with oral sulforaphane
时间窗: 2 years
Visual changes of atypical nevi: size, border, color.
时间窗: 2 years
Cellular changes of the atypical nevi.
时间窗: 2 years
次要结局
- Sulforaphane levels in the blood as a result of the 3 doses.(2 years)
- Effects of sulforaphane on STAT1 and STAT3 expression.(2 years)
研究者
John Kirkwood
Professor and Vice Chairman for Clinical Research
University of Pittsburgh