Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 16
- 主要终点
- Lung Cancer Recurrence or Mortality - 2 Years
研究概览
简要总结
There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.
详细描述
The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non small cell lung cancer
- •Eligible for surgical resection
- •Willingness to adhere to randomized treatment
- •Availability for follow-up schedule of visits
排除标准
- •Taking exogenous melatonin
结局指标
主要结局
Lung Cancer Recurrence or Mortality - 2 Years
时间窗: 2 years
Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years.
次要结局
- Quality of Life(2 years)
- Anxiety(2 years)
- Depression(2 years)
- Pain Levels(3 months)
- Adverse Events (Chemotherapy)(2 years)
- Adverse Events (Radiation)(2 years)
- Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)(6 months)
- Fatigue(2 years)
- Sleep(2 years)
- Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)(6 months)
- Lung Cancer Recurrence or Mortality - 5 Years(up to 5 years)