A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- quality of life
研究概览
简要总结
Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.
详细描述
The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
The inclusion criteria included:
- Patients shall have normal organic function such as liver function, Cardiac function and renal function.
- Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- Patients should be expected to live no shorter than 1.5 months
The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
- •Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
- •Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- •Patients should be expected to live no shorter than 1.5 months
排除标准
- •Patients receiving other anti-cancer drugs;
- •Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
- •Patient with inadequate Blood system,liver function and renal function.
- •Brain metastasis is of symptoms
- •Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
- •Chronic enteritis or intestinal obstruction
- •Bone marrow failure
- •Mental disease difficult to control
- •Participated other clinic trial within 3 months
- •Pregnant or lactation patients
- •The researcher evaluate the patient is not suitable for this trial.
研究组 & 干预措施
placebo plus gemcitabine
we design placebo plus gemcitabine as control arm
干预措施: Gemcitabine, placebo (Drug)
Mirtazapine plus gemcitabine
We design Mirtazapine plus gemcitabine as experimental arm
干预措施: Mirtazapine plus gemcitabine (Drug)
结局指标
主要结局
quality of life
时间窗: up to 3 years
primary outcome is the quality of life evaluated by SF-36 scale
次要结局
- anxiety and depression scores(up to 3 years)
- objective response rate(up to 3 years)
- progress free survival,(up to 3 years)
- overall Survival(up to 3 years)
- chemotherapy induced nausea and vomiting(up to 3 years)