Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
试验速览
- 阶段
- 2 期
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Quality of Life (FACT-B Version 4)
研究概览
简要总结
The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free 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
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven stage II or III breast 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)
- •New York Heart Association grade ≤ 2
- •written consent
排除标准
- •received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization,
- •had more than one type of cancer or brain metastasis
- •moderate neuropathy (CTCAE grade ≥ 2)
- •active infection
- •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: match placebo (Drug)
Melatonin 20mg
20 mg melatonin gelatin capsule
干预措施: Melatonin (Drug)
结局指标
主要结局
Quality of Life (FACT-B Version 4)
时间窗: Change from baseline in TOI scores at 6 months
Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.
次要结局
- Cancer recurrence incidence(participant will be followed for the duration of study, an expected average of 2 years)
- Number of participants with adverse events(Baseline and months 2,3,4,5,6,12,18,24)
- Progression-free survival(participant will be followed for the duration of study, an expected average of 2 years)
- Pain and amount of pain medication used(Before and up to 72 hours after surgery.)
- Sleep quality(Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24)
研究者
Nutjaree Pratheepawanit Johns
Associate Professor
Khon Kaen University