SUPPLEMENTATION OF VITAMIN E, C and ZINC IN PATIENTS WITH NON-MELANOMA SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- OXIDATIVE STRESS BIOMARKERS
研究概览
简要总结
The objective of this study was to evaluate the effects of supplementary antioxidant therapy on the levels of biomarkers and inflamatory citocines in patients with a previous history of non-melanoma skin cancer treated with surgery. This was a double-blind, randomized, placebo-controlled trial. Patients were randomized into two groups, one receiving placebo (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50 mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite, thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two different times: (1) one day before the start of supplementation or placebo administration and (2) at 60 days after intervention. Statistical analyses were performed with the SAS System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell carcinoma) and who were treated with surgery
- •age ≥20 years
- •absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer
- •no history of chemotherapy or radiotherapy in the previous 6 months
- •absence of severe psychiatric disease that limited comprehension
- •not taking any vitamin and/or mineral supplementation.
排除标准
- •subjects did not complete the entire course of supplemental therapy.
结局指标
主要结局
OXIDATIVE STRESS BIOMARKERS
时间窗: one day before the start of supplementation or placebo administration and at 60 days after intervention
8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)
INFLAMMATORY STATE
时间窗: one day before the start of supplementation or placebo administration and at 60 days after intervention
IL-1, IL-6, IL-10, TNF alfa
次要结局
未报告次要终点
研究者
Patricia Moriel
PhD
University of Campinas, Brazil