Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Quality of Life (FACT)
研究概览
简要总结
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- •platelet count ≥100,000 cells/mm3
- •white blood cell count ≥ 3,000 cell/mm3
- •hemoglobin ≥ 10 g/dL
- •serum creatinine ≤ 1.5 mg/dL
- •bilirubin ≤ 2 mg/dL
- •AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5 times UNL for those with liver metastases
- •New York Heart Association grade ≤ 2
- •written consent
排除标准
- •Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization
- •Patients who have more than one type of cancer or brain metastasis were excluded from the trial.
- •Patients with moderate neuropathy (CTCAE grade ≥ 2)
- •Patients with an active infection, or uncontrolled complications (i.e. blood glucose > 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).
研究组 & 干预措施
Matched placebo
Matched placebo (identical formulation and delivery, without active ingredient)
干预措施: Matched placebo (Drug)
Drug: 10 mg Melatonin
10 mg melatonin gelatin capsule
干预措施: 10 mg Melatonin (Drug)
Drug: 20 mg Melatonin
20 mg melatonin gelatin capsule
干预措施: 20 mg Melatonin (Drug)
结局指标
主要结局
Quality of Life (FACT)
时间窗: Change from baseline in total scores at 6 months after treatment
Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.
次要结局
- Number of participants with adverse events(Baseline and 1,2,3 and 6 months after treatment)
- Oxidative stress status(Chemotherapy cycles 1,2,3,4)
- Melatonin level(Chemotherapy cycle 1,2,3 and 4)
- Overall survival(Over 4 years of the study)
研究者
Nutjaree Pratheepawanit Johns
Associate Professor
Khon Kaen University