A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
研究概览
简要总结
This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have at least 2 nevi (each >6 mm diameter) not clinically suspicious for melanoma that can be biopsied.
- •Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •The patient is a minor (< 18 years old).
- •The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed)
- •The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.)
- •The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
- •The patient has history of allergic reaction to NAC.
- •The patient has history of severe asthma.
- •The patient has been taking NAC or any other oral antioxidant.
- •The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.
研究组 & 干预措施
Patients receiving N-acetylcysteine
Patients receiving NAC (N-acetylcysteine)
干预措施: N-acetylcysteine (Drug)
Placebo Group
Participants not receiving NAC (N-acetylcysteine)
干预措施: Placebo arm (Other)
结局指标
主要结局
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
时间窗: 3.5 years
Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.
次要结局
- Transcriptional Markers of UV-induced Oxidative Stress in Nevi(3.5 years)