A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change in minimal erythemal dose (MED) from baseline to day 60.
研究概览
简要总结
This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.
详细描述
While melanoma risk is largely genetically determined, exposure to ultraviolet (UV) radiation in sunlight is the major environmental risk factor. Although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly.
This study will evaluate the downstream effects of aspirin (ASA) in human blood and skin moles (nevi) following oral ingestion. We will determine if chronic ingestion of ASA can modulate UV-sensitivity of the skin, UV-induced damage in nevi, and PGE2 levels in blood and nevi.
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
- Double (Participant, 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
- 否
入选标准
- •Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
- •Must be older than age
- •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 cannot speak / understand English or Spanish.
- •The patient is pregnant or breastfeeding.
- •The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
- •The patient has history of allergic reaction to ASA.
- •The patient has history of severe asthma.
- •The patient has been taking ASA or any NSAID in the past 2 weeks.
- •The patient has been taking a blood thinner in the past 2 weeks.
- •The patient has history of bleeding disorder.
- •The patient has history of peptic ulcer disease.
- •The patient has had recent intense UV exposure in the past month.
研究组 & 干预措施
ASA 81 mg daily
Participants will be given ASA 81 mg orally once daily for a total of 60 days
干预措施: Aspirin 81 mg (Drug)
ASA 325 mg daily
Participants will be given ASA 325 mg orally once daily for a total of 60 days.
干预措施: Aspirin 325mg (Drug)
Placebo
Participants will be given a placebo orally once daily for a total of 60 days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in minimal erythemal dose (MED) from baseline to day 60.
时间窗: Change from baseline to day 60
Baseline minimal erythemal dose (MED) measurements will will be compared to MED results at day 60. We will use the conventional definition of MED as the lowest UV dose resulting in erythema that completely fills the 8-mm irradiated site (homogeneous erythema).
Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60.
时间窗: Change from baseline to day 60
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.
Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60.
时间窗: Change from baseline to day 60
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.
次要结局
- Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.(Change from baseline to day 60)
- Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60.(Change from baseline to day 60)
- Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in nevus tissue from baseline to day 60.(Change from baseline to day 60)
- Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.(Change from baseline to day 60)