Randomized, Double-blinded, Placebo-controlled, Single Center, and Prospective Phase II Clinical Trial to Analyze the Effects of Antioxidant Agents on DNA Double-strand Breaks in Patients After Radiation-based Cardiac Examinations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
研究概览
简要总结
Trial with medicinal products
Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the number of DNA double-strand breaks.
This study represents a prospective, double-blinded, randomized, single center, and placebo-controlled phase II clinical trial which analyzes the capability of antioxidant agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in patients undergoing radiation-based cardiac examinations (30 patients with high-dose radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without radiation exposure).
A protective effect of antioxidant drugs in patients undergoing radiation-based examinations could therefore change patient management and would provide an important clinical impact.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •18-70 years of age
- •European origin
- •Non-smoker
- •30 patients with high-dose radiation exposure from a cardiac examination
- •30 patients with low-dose radiation exposure from a cardiac examination
- •30 subjects without radiation exposure
- •Given written informed consent
- •Ability to participate in the study
排除标准
- •no known intolerance against one of the applied study drugs or against substances used for formulation of one of the study drugs or against other drugs with similar chemical structures as one of the study drugs
- •Radio- or chemotherapy
- •Severe renal failure (GFR<30 ml/min)
- •Positive pregnancy test or lactation
- •Radiation-based examination within the last 3 days
- •Known glucose-6-phosphate-dehydrogenase deficiency
- •Known nephrolithiasis (calciumoxalate calculus)
- •Intake of barbiturates, tetracyclines, corticosteroids within the last 4 weeks
研究组 & 干预措施
N-acetylcysteine
This arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: Low-dose radiation exposure (Radiation)
N-acetylcysteine
This arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: High-dose radiation exposure (Radiation)
N-acetylcysteine
This arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: No radiation exposure (Other)
Ascorbic acid
This arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: Low-dose radiation exposure (Radiation)
Ascorbic acid
This arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: High-dose radiation exposure (Radiation)
Ascorbic acid
This arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: No radiation exposure (Other)
Sodium Chloride (NaCl)
This arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: Low-dose radiation exposure (Radiation)
Sodium Chloride (NaCl)
This arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: High-dose radiation exposure (Radiation)
Sodium Chloride (NaCl)
This arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
干预措施: No radiation exposure (Other)
结局指标
主要结局
Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
时间窗: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks under the influence of n-acetylcystein or ascorbic acid will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis) and will be compared to study patients administered with placebo (using the same quantifiaction tools).
次要结局
- Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid(Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure)
- Change in the number of DNA double-strand breaks between no, low, and high radiation exposure(Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure)